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About this blog

I am a Neonatologist trained in Winnipeg, Manitoba and Edmonton, Alberta.  My current position is Section Head of Neonatology in Manitoba and over my career my interests have meandered from time to time.  I have been a past Program Director of Neonatology and Medical Director for a level II Intensive Care Unit prior to relocating to Winnipeg become a Section Head.

Welcome to my blog which I hope will provide a forum for discussion on topics that are of interest to Neonatologists, trainees, all health care professionals and in some cases parents of those we care for.  My intent is to post opinions and analysis on both items from the media and literature that pertain to neonates.  While I have many interests, my particular motivation is to find ways to reduce discomfort for the patients that we care for.  Whether it is through the use of non-invasive testing or finding a way to improve the patient experience this is where I find myself most energized.

I chose the picture for this site as since the inception of this site there is hardly a country that has not had an individual or many people view posts.  Moreover I have received comments from many people from so many different countries that have inspired me to think not just about the impact of these posts in North America but more globally as well.

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Entries in this blog

 

Why do we keep treating reflux in preemies?

Choosing wisely is an initiative to “identify tests or procedures commonly used whose necessity should be questioned and discussed with patients. The goal of the campaign is to reduce waste in the health care system and avoid risks associated with unnecessary treatment.” The AAP Section on Perinatal Pediatrics puts the following forth as one of their recommendations. “Avoid routine use of anti-reflux medications for treatment of symptomatic gastroesophageal reflux disease (GERD) or for treatment of apnea and desaturation in preterm infants. Gastroesophageal reflux is normal in infants. There is minimal evidence that reflux causes apnea and desaturation. Similarly, there is little scientific support for the use of H2 antagonists, proton-pump inhibitors, and motility agents for the treatment of symptomatic reflux. Importantly, several studies show that their use may have adverse physiologic effects as well as an association with necrotizing enterocolitis, infection and, possibly, intraventricular hemorrhage and mortality.” How strong is the evidence? The evidence for risk with acid suppression is largely based on either retrospective or in the case of Terrin G et al a prospective observational cohort study Ranitidine is Associated With Infections, Necrotizing Enterocolitis, and Fatal Outcome in Newborns.  In this study the authors compared a group of premature infants with birth weights between 401 – 1500g or 24 – 32 weeks gestation who received ranitidine for reflux symptoms to those who did not.  All told 91 were exposed while 183 were not.  The authors are to be commended for standardizing the feeding protocol in the study so that when comparing NEC between groups one could not blame differences in formula consumption or rate of feeding advancement.  Additionally, bias was controlled by having those not involved in care collect outcome data without knowing the purpose of the study.  Having said that, they may have been able to ascertain that ranitidine was used and have been influenced in their assessments. The patients in terms of risk factors for poor outcome including CRIB and apgar scores, PDA etc were no different to explain an increased risk for adverse outcome. From the above table, rates of infections were clearly higher in the ranitidine group but more concerning was the higher rate of mortality at 9.9% vs 1.6% P=0.003 and longer hospitalization median 52 vs 36 days P=0.001. Results of a Meta-Analysis Additional, evidence suggesting harm comes from a meta-analysis on the topic by More K, Association of Inhibitors of Gastric Acid Secretion and Higher Incidence of Necrotizing Enterocolitis in Preterm Very Low-Birth-Weight Infants.  This analysis actually includes the study by Terrin and only one other retrospective database study of 11072 patients by Guillet et al.  As the reviewers point out the study by Terrin while prospective did not employ the use of multiple regression to adjust for confounders while the larger study here did.  In the end the risk of NEC with the use of acid suppression was 1.78 (1.4 – 2.27; p<0.00001). What do we do with such evidence? I can say this much.  Although small in number, the studies that are available will make it very difficult to ever have a gold standard RCT done on this topic.  This scant amount of evidence, backed by the biologic plausibility that raising the gastric pH will lead to bacterial overgrowth and potential aspiration of such contents provides the support for the Choosing Wisely position. Why do we continue to see use of such medications though?  It is human nature I suspect that is the strongest motivator.  We care for infants and want to do our best to help them through their journey in neonatal units.  When we hear on rounds that the baby is “refluxing” which may be documented by gulping during a brady, visible spit ups during A&Bs or through auscultation hearing the contents in the pharynx we feel the need to do something.  The question invariably will be asked whether at the bedside or by the parents “Isn’t there something we can do?”. My answer to this is yes.  Wait for it to resolve on its own, especially when the premature infants are nowhere close to term.  I am not sure that there is any strong evidence to suggest treatment of reflux episodes with gastric acid suppression helps any outcomes at all and as we see from the Terrin study length of stay may be prolonged.  I am all in favour of positional changes to reduce such events but with respect to medications I would suggest we all sit on our hands and avoid writing the order for acid suppression.  Failure to do so will likely result in our hands being very busy for some infants as we write orders to manage NEC, pneumonia and bouts of sepsis.  

AllThingsNeonatal

AllThingsNeonatal

 

Has the Magic Bullet to Prevent Kernicterus Been (Re)Discovered?

As the saying goes "What is old is new again" and that may be applicable here when talking about prevention of kernicterus.  In the 1990s there was a great interest in a class of drugs called mesoporphyrins in the management of hyperbilirubinemia.  The focus of treatment for many years had been elimination of bilirubin through the use of phototherapy but this shifted with the recognition that one could work on the other side of the equation.  That is to prevent the production of bilirubin in the first place. Tin mesoporphyrins (SnMP) have the characteristic of being able to inhibit the enzyme hemo oxygenase quite effectively.  By achieving such blockade the breakdown of heme to carbon monoxide and biliverdin (the precursor of bilirubin) is inhibited.  In so doing, the production of bilirubin is reduced making one less dependent on phototherapy to rid the body of elevated levels.  So simple and as you might imagine a good reason for there to have been significant interest in the product.  One article by Martinez et al entitled Control of severe hyperbilirubinemia in full-term newborns with the inhibitor of bilirubin production Sn-mesoporphyrin. was published in 1999 and demonstrated that infants with severe hyperbilirubinemia between 48-96 hours could have their need for phototherapy eliminated by use of the product compared to 27% of the infants in the control group needing treatment.  Additionally, total bilirubin samples were reduced from a median of 5 to 3 with the use of one IM injection of SnMP.  This small study was hampered though by inability to really look at adverse outcomes despite its effectiveness.  What has been seen however is that SnMP if given to infants who are then treated with white lights can create a rash which is not seen however when special blue light is employed. Two other studies followed exploring the use of SnMP in cases of severe hyperbilirubinemia in term infants and were the subject of a Cochrane review in 2003.  The conclusions of the review essentially became the death nell for the therapy as they were as follows. "...may reduce neonatal bilirubin levels and decrease the need for phototherapy and hospitalization. There is no evidence to support or refute the possibility that treatment with a metalloporphyrin decreases the risk of neonatal kernicterus or of long-term neurodevelopmental impairment due to bilirubin encephalopathy... Routine treatment of neonatal unconjugated hyperbilirubinemia with a metalloporphyrin cannot be recommended at present." The literature after this basically dries up, that is until this month when a paper emerges that is best described as a story of mystery and intrigue! Prophylactic Use of SnMP From 2003 Published in 2016! This paper as you read it almost seems like a conspiracy story.  The paper is by Bhutani et al (as in the nomogram) Clinical trial of tin mesoporphyrin to prevent neonatal hyperbilirubinemia.  The study set out to answer a different question than had been previously studied.  The question here was, if you provided a single IM dose of SnMP to infants who were at or above the 75%ile on the risk nomogram, could you prevent the need for phototherapy or exchange transfusion as the primary outcome.  Secondarily, the authors truly wanted to demonstrate safety of the product and planned on recruiting 800 patients per arm in the study.  The study appeared to be well planned and as with many studies had a safety monitoring committee which was to do interim analyses.  After the first analysis the FDA became involved and recommended studies to look at a prophylactic versus therapeutic approach.  Due to the interim analysis the study had been halted and after the FDA made their suggestion the study was simply never restarted as future studies were planned to look at the effectiveness and safety of the two approaches.  The authors state that they planned on reporting their results in 2006/7 but elected to wait until long term data emerged.  Now finally 9 years later they decided to release the results of the partially completed study.  The story around this study I find as interesting as the results they obtained! So What Happened? Before closing the study they managed to recruit 87 into the intervention arm and 89 into the placebo group and lost none to follow-up.  One dose of SnMP had a significant effect on the trajectory of curves for bilirubin production as can be seen in the first figure.   The graph below demonstrates what percentage of patients had a bilirubin level above 220 umol/L (12.9 mg/dl) after the single injection of SnMP (black bars) compared to placebo (white bars). What can we do with these results? It would be tough to argue anything other than this being an effective treatment to prevent significant hyperbilirubinemia.  Unfortunately, like many studies that were never completed this one remains underpowered to conclusively demonstrate that the use of SnMP is safe in both the short and long term periods.  The absence of such data make it very difficult to recommend SnMP as standard of care.  One has to add to this that while we have evidence to show it reduces the rate of rise of bilirubin, what we don't know is whether in a larger study the incidence of bilirubins > 425 umol/L or the need for exchange transfusion might be reduced.  If this were the case, it would make for a compelling argument to try SnMP. That is the approach for standard of care though.  In the setting of a patient with a known blood group incompatibility who was at high risk for exchange transfusion, if they received IVIG and the bilirubin continued to climb might there be a role here?  I would tend to say yes if we could get our hands on some.  The authors by sharing this data have shown the medication is effective in doing what it is supposed to do.  Given that at least in our centre all of our lights are of the new variety, the risk of rash would be nonexistent.  The risk for kernicterus or at least an exchange transfusion though would not be minimal so if we have this in our toolbox I would after weighing the risks opt to give it. I certainly wonder if there are places out there who have used it and if so what is your experience?

AllThingsNeonatal

AllThingsNeonatal

 

Skin-to-skin fad blamed for deaths of babies!

As the practice seems to be winning the world over you can imagine that a headline entitled, 'Skin-to-skin' fad blamed for deaths of babies would get some attention.  This article was sent to me by a colleague after being published last month on Yahoo news service.  The claim is based on the experience of a hospital in Perth that has seen some cases of neonatal suffocation after mothers who were performing skin to skin care fell asleep and rolled onto their newborn.  This "fad" they say is attributable as the cause of death.  Before looking into whether there is any basis for such a claim it may be worth exploring whether Kangaroo Care (KC) otherwise known as Skin to Skin (STS) care is effective. Is KC Effective in the NICU? KC or is an ideal method of involving parents in the care of their premature infant.  It fosters bonding between parents and their hospitalized infant, encourages the family to be with their child and thereby exposes them to other elements of neonatal care that they can take part in. Before you reach the conclusion that KC only serves to enhance the parental experience it does so much more than that.  The practice began in Bogota Columbia in 1979 in order to deal with a shortage of incubators and associated rampant hospital infections.  The results of their intervention were dramatic and lead to the spread of this strategy worldwide.  The person credited with helping to spread the word and establish KC as a standard of care in many NICUs is Nils Bergman and his story and commentary can be found here. The effects of KC are dramatic and effective to reduce many important morbidities and conclusively has led to a reduction in death arguably the most important outcome.  An analysis of effect has been the subject of several Cochrane Collaboration reviews with the most recent one being found here. To summarize though, the use of KC or STS care has resulted in the following overall benefits to premature infants at discharge or 40 - 41 weeks' postmenstrual age: Reduction in mortality  (typical RR 0.68, 95% CI 0.48 to 0.96) nosocomial infection/sepsis  (typical RR 0.57, 95% CI 0.40 to 0.80) hypothermia (typical RR 0.23, 95% CI 0.10 to 0.55) Increase in KMC was found to increase some measures of infant growth, breastfeeding, and mother-infant attachment To put this in perspective, medicine is littered with great medications that never achieved such impact as simply putting your child against your chest.  This is another shining example of doing more with less.  This is not to say that modern medicine and technology does not have its place in the NICU but KC is simply too powerful a strategy not to use and promote routinely in the NICU. What About Term Infants? Much has been written on the subject.  A Pilot study in 2007 by Walters et al found benefits in newborn temperature, glycemic control and initiation of breastfeeding.  Perhaps the strongest evidence for benefit comes from a cochrane review of the subject last updated in 2012. Early skin-to-skin contact for mothers and their healthy newborn infants. This analysis included 34 RCTs with 2177 participants (mother-infant dyads). Breastfeeding at one to four months postbirth (13 trials; 702 participants) (risk ratio (RR) 1.27, 95% confidence interval (CI) 1.06 to 1.53, and SSC increased breastfeeding duration (seven trials; 324 participants) (mean difference (MD) 42.55 days, 95% CI -1.69 to 86.79) but the results did not quite reach statistical significance (P = 0.06). Late preterm infants had better cardio-respiratory stability with early SSC (one trial; 31 participants) (MD 2.88, 95% CI 0.53 to 5.23). Blood glucose 75 to 90 minutes following the birth was significantly higher in SSC infants (two trials, 94 infants) (MD 10.56 mg/dL, 95% CI 8.40 to 12.72). Taken together there are benefits although the impact on breastfeeding rates in term infants show a strong trend while not reaching statistical significance.  Importantly though in this large sample we don't see any increase in mortality nor to my knowledge has there ever been a study to show an increase. How do we deal with this claim from Australia then? I think the problem with this claim is that KC is being blamed after a "root cause analysis" has come to the wrong conclusion.  The problem is not KC but rather a lack of a "falls prevention" strategy on the postpartum units.  Mothers after delivery are exhausted and may be on pain medication so as the saying goes "there is a time and a place".  As our hospital prepares for accreditation again, safety to prevent falls (including babies falling out of mom's arms or in a similar vein mothers falling onto babies) is something that every hospital needs.  Whether a mother is practicing KC, breastfeeding or simply holding her baby if a mother falls asleep while doing so there is a risk to the infant.  If the hospital in this case has seen an increase in such cases of newborn deaths while performing KC then it is likely the hospitals lack of attention to minimizing risk in the postpartum period that is to blame and not KC itself.  Certainly the evidence from rigorously done trials would not support this claim. This hospital would do well to have a comprehensive plan to educate parents about the risks of fatigue, ensure bassinets are next to every bed to provide mothers with an easy transfer if they are tired.  Certainly during the immediate period after delivery mothers, partners of mothers who have just delivered should be encouraged to be with them or advise the mothers if they are tired to put the baby down and rest.  A little education could go a long way! I think it is a cheap out to blame KC for such problems as it turns our attention away from the real issue and that is a lack of policy and education.  So in the end I would like to state emphatically that... No I don't believe the "skin-to-skin fad" is to blame for an increase in deaths!          

AllThingsNeonatal

AllThingsNeonatal

 

Micropreemie Lives Matter

It seems the expression "(insert a group) lives matter" is present everywhere these days so I thought I would join in after a moving experience I had today.  For those of you who have been with the blog since the beginning you would have seen a number of posts that if you follow them in time, provide a glimpse into the transformation that Winnipeg has seen over the last year or so. Prior to that point, 24 weeks was a cutoff for resuscitation that had been in place for some time and after a great amount of deliberation and thought was changed to 23 weeks.  This did not come without a great deal of angst and a tremendous amount of education and teamwork that our nurse educators and clinical leads were so instrumental in helping to role out.  The experience was outlined in a couple of posts that you may find interesting if you didn't catch them the first time.  The first was Winnipeg hospital now resuscitating all infants at 22 weeks! A media led case of broken telephone. and the second being Winnipeg Hospital About to Start Resuscitating Infants at 23 weeks! Since these two posts we have certainly had our fair share of experience as we have seen far more babies than anticipated but the region has met the challenge head on and although the numbers are small we appear to have not only more survivors than expected but all but one infant had gone home without O2 and all have been demand feeding at discharge.  While we await the 18 month outcomes, the results thus far appear reassuring. A Special & Memorable Visit Then today, a visit occurred from the first of such infants who is now just over a year of age.  He was bright eyed, smiling, interactive and by his parent's account, has normal tone and assessments thus far by physiotherapy.  His presence in the NICU put smiles on faces and at least for myself made me think of the expression "Micropreemie Lives Matter".  He was a baby that everyone predicted would not survive and then when he did, that he would be grossly developmentally impaired which he does not appear to be in the least.  His presence in the unit no doubt gives everyone who doubted the merits of moving down this path reason to pause. Before you accuse me of wearing rose coloured glasses, make no mistake I know that he will not represent the outcome for everyone.  In fact at one of our hospitals two of such infants have died while we await the 18 month outcomes for the other survivors.  What his presence does though, is remind us or at least me that good outcomes are possible and in the case of our experience in Winnipeg may be more common that we thought they would be. Black Swans and Human Nature When I have spoken to audiences about the path forward when resuscitating such ELGANS I have often commented on the "Black Swan" effect.  This was very nicely described by Nassim Taleb and described the human trait to react to unusual events with extreme reactions.  An example is no one wanting to fly in the months after the world trade centre bombing when statistically this may have been the safest period in history to fly.  Similarly, we as a team need to avoid the extreme reaction of saying that we should not be resuscitating such small infants when a bad outcome occurs.  As I have told many people, we know these patients will not all survive, we know a significant number will have adverse development yet not all will and at least in our small sample thus far the babies would appear to be doing better overall than anticipated.  If we know that bad outcomes will occur then why do we hear the questions come when they do such as "why are we doing this?", "maybe we should rethink our position on 23 week infants".  It happens because we care and we hate seeing families and their babies go through such painful experiences.  What we cannot do though for the sake of those such as our visitor today is react with a "Black Swan" reaction and steer the ship so to speak in the previous direction we were in.  There are survivors and they may do well and that is why I say "Micropreemie Lives Matter". In the paper by Rysavy the overall finding at 23 weeks was that 1 out of 6 would survive without moderate or severe disability.  What do we do as we increase our experience if the trend bears out that our outcomes are better?  How will we counsel families? Will we continue to use the statistics from the paper or quote our own despite us being a medium sized centre? The Big Questions As our experience with such infants increases we will also no doubt see a change in our thoughts about infants at 24 weeks.  I have seen this first hand already with a physician commenting today that 24 weeks is not such a big deal now!  This brings me to the big question (which I will credit a nurse I work with for planting in my head in the last two weeks) which is for another time to answer as this post gets a little lengthy but is something to ponder.  As our outcomes for 23 weeks improve and so do our results at 24 weeks (which is bound to happen with the more frequent team work in such situations) will our approach to infants at 24 weeks change.  In our institution we generally follow the CPS guidelines for the management of infants at extremely low GA and offer the choice of resuscitation at 24 weeks.  As outcomes improve at this GA will we continue to do so or will we reach a threshold where much like the case at 25 weeks we inform families that we will resuscitate their infant without providing the option of compassionate care? It is too early to answer these questions conclusively but they are very deserving of some thought.  Lastly, I would like to thank the parent who came by today for inspiring me and to all those who will follow afterwards.

AllThingsNeonatal

AllThingsNeonatal

 

Believe it or not? Injections For ROP Causing Brain Damage.

The media loves a good story and when a medication that has been given to children may have a link to "brain damage" you better believe it will gain some traction. Ever since the first reports began emerging suggesting laser treatment for ROP may have an alternative in Avastin (bevicizumab) skeptics have abounded.  After the link was established between high vascular endothelial growth factor (VEGF) and ROP it was not long before the thought of using Bevicizumab to reduce abnormal vessel proliferation of the developing retina.  This medication is an anti-VEGF medication that had been used for treatment of colorectal cancer and with this link to ROP a new use had been found for an existing drug. It was big news and created a great stir in many units around the world. What followed was solid research demonstrating efficacy with the BEAT-ROP being the most influential trial.  The full text of this study can be found here.  The results of this study of 150 infants (300 eyes) clearly demonstrated that for those with 3+ disease in zone 1, outcomes were better than if laser was used for treatment.  For Zone 2 disease there really was no benefit to Bevicizumab but due to the ablative nature of laser, infants in the long run (particularly for Zone 1 disease) can be left with visual compromise later in life including myopia, strabismus as well as amblyopia. It is for these reasons that I have to confess I have been quite keen on Bevicizumab although at least in our own centre laser in general continues to be presented as standard of care with the option for injection.  For Zone 1 disease though Bevcizumab is becoming increasingly recommended due to the aforementioned visual sparing effects in the long run. What is the concern with Avastin? The main issue as with any new treatment is the question of whether there are any long term consequences to using a medication that could distribute systemically.  We know that many ocular medications can enter the rest of the body and given that VEGF is found in virtually every organ system in the body it is appropriate to express some caution before laser is replaced as standard of care.  Anti-VEGF activity could for example cause abnormal vascular development in the lungs of these fragile infants who are trying to recover from BPD and make a disease that already has a vascular component worse.  A more direct concern could be the effect of altering vascular development so close to the brain with the potential fear of causing developmental impairment as a result.  It may seem surprising that there is so little out there on the topic until you consider that the BEAT-ROP study was published in 2011.  This is the time five years later that we should expect to see some outcome results and now we have. Drug Used For Preemie Eye Disease Tied To Disabilities This was the title this week of an AAP update after the following article was published Neurodevelopmental Outcomes Following Bevacizumab Injections for Retinopathy of Prematurity by Morin J using data from the Canadian Neonatal Network.  The trial is important as data is needed on the outcome of these infants but the message that is coming out of this publication is worrisome to me in that conclusions are being drawn from a study that has significant concerns.  The main findings that have raised many an eyebrow were the following comparing injection to laser in that order for the percentages. Neurodevelopmental Impairment: 78% vs 56% Severe Neuro disability:  52% vs 29% The usual concerns are here in that the study is retrospective and therefore prone to the usual types of error in having groups unbalanced.  One of these imbalances is in the severity of illness at admission as measured by the SNAP-II score.  The babies treated with injections were sicker and significantly so.  The scores in this case were medians of 24 in the Bevicizumab group vs 19 in the laser group.  This is quite significant as another group using the CNN data previously published their findings in 2013 that among other things the SNAP-II score was predictive of adverse outcome in a group of infants from 23-30 weeks (same group that is screened for ROP) if the score was above 20.  Indeed in the current study the median score for the group treated with Bevicizumab was above this threshold so is the treatment the issue or the fact that the babies were sicker to begin with? The second significant concern I have with this study is the nature of the babies who were treated with injection vs laser. Based on the BEAT-ROP study most centres reserve injections for the most severe Zone 1 disease and that was no different here.  The babies receiving injections had aggressive Zone 1 disease 19% of the time compared to the laser group at 7%.  These babies had worse eye disease but how does that tie in to long term neurodevelopment?  Several papers have linked adverse developmental outcome by itself to the severity of ROP that the infants had.  One such paper by Msall looked at the outcome from the CRYOROP study and found exactly this in a follow up of 1199 survivors so a very large study to draw conclusions from. So we have the current study suggesting that adverse neurodevelopmental outcome is associated with receiving injections for ROP.  We also have two very clear confounders that one cannot ignore.  The babies who received injections were both sicker at admission and had worse eye disease overall which both are predictive of adverse outcome.  Add to this that another retrospective study that is not much smaller than this found no difference in outcome and I think the conclusions of the current CNN paper are suspect.  Interestingly I don't recall seeing any media attention for this negative study but then that tends to be the way these types of results are handled.  Kind of boring so not worth reporting? Where do we go from here? What we really need now is a double blind randomized controlled trial to sort this out.  It needs to be large enough such that the SNAP-II scores are not significantly different and injections and laser need to truly go head to head.  This could be accomplished by following up the BEAT-ROP group or by repeating another trial with the primary outcome being neurodevelopment.  In the meantime I would urge everyone to take a breath and not panic.  While I confess I have a bias towards Bevicizumab for its vision sparing advantages there could be an impact on development that we cannot ignore.  We need to study this well though and that will take some time. Until we do both the scientific community and the lay press need to carefully weigh the merits of releasing studies with significant sources of confounding risks as a little fear can be a strong motivator and potentially deprive infants in the NICU of an important option for treatment.      

AllThingsNeonatal

AllThingsNeonatal

 

Are Antibiotics Really Necessary For Meconium Aspiration Syndrome?

We live in a world at the moment where the public has become increasingly aware of the dangers of antibiotic overuse.  Parents are more than ever requesting no erythromycin for the eyes after birth, and even on occasion questioning the need for antibiotics after delivery for the infant with risk factors for sepsis.  The media has latched on to the debate as well by publishing the sensational articles about superbugs and medicine running out of the last lines of defence such as this article from the CBC. As teams caring for newborns both preterm and term we are also increasingly aware of the dangers of altering the microbiome of these vulnerable infants with antibiotic overuse. Some babies robbed of the vaginal microbiome when delivery occurs by C-section, have their parents swabbing their newborn with vaginal secretions to populate their child with the "good bacteria" that come through a "natural" delivery although recent commentary questions the safety of such practice. Infants born through meconium stained amniotic fluid can certainly become sick after delivery.  Inhalation of meconium in the sickest infants often occurs during gasping episodes in utero after hypoxic stress causes evacuation of the rectal contents.  The fetuses who inhale this material may go on to develop, inflammatory changes, areas of atelectasis and hyperinflation and pulmonary hypertension; the so called meconium aspiration syndrome.  These infants of course may be extremely sick and need high frequency ventilation to manage their CO2 retention and in some cases may go on to ECMO although with inhaled nitric oxide this has become less common.  As another consideration, could infection such as chorioamnionitis be the inciting event to cause passage of meconium in utero? The health care team though for as long as I have been in practice would add to the treatment plan a course of antibiotics.  In fact I would guess that many Neonatologists the world over have uttered the phrase "They are REALLY sick, please start antibiotics".  The real question though is whether the baby is in fact infected.  Meconium is certainly a good growth medium for bacteria but with the short time from passage to delivery in most cases I doubt there is much time for significant growth.  Moreover, I have found myself saying many times that such infants have a chemical pneumonitis and have often questioned whether antibiotics are really needed.  Nonetheless it would take nerves of steel in some cases to not use antibiotics in these patients. Then along came this study Role of prophylactic antibiotics in neonates born through meconium-stained amniotic fluid (MSAF)—a randomized controlled trial by Goel A et al.  This study was done prospectively by randomizing newborns born through meconium stained amniotic fluid to either antibiotics (N=121) for three days or no antibiotics (N=129) after diagnosis.  In each case blood and CRP were drawn and if the infant was symptomatic (presence of respiratory distress, lethargy, abdominal distension, temperature or hemodynamic instability, hypoglycemia, apnea, or any other systemic abnormalities) a lumbar puncture and chest x-ray were added.  The primary outcome variable was defined as " the incidence of early (within first 72 h of birth) or late onset (after 72 h of birth) suspect sepsis (clinical symptoms or positive sepsis screen defined as ≥2 positive parameters) and confirmed sepsis (positive blood culture)." Results Clinicians in the study were allowed to continue antibiotics past the 72 hours or start antibiotics in the no antibiotic group if they considered an infant to have suspected sepsis or in fact were found to be proven.  The outcomes for those possibilities are shown below. Taking it all together whether you started antibiotics or not the primary outcomes were no different.  Furthermore there is no apparent harm based on outcomes that matter including the most important; death (3 in each group) that it does give one reason to pause when considering whether to treat prophylactically with antibiotics for babies born through meconium stained fluid. What About The Sickest of The Sick When attempting to answer this question the authors noted the following. "On doing a subgroup analysis on incidence of sepsis in symptomatic babies (presenting with respiratory distress), both groups were found to have comparable incidence of suspect sepsis (p=0.084). The incidence of confirmed sepsis was more in symptomatic babies, although the total numbers was very few (p=0.01)" Herein lies the challenge in declaring once and for all that we don't need antibiotics at all in MAS.  While the study was powered to adequately answer the primary outcome, the subgroups are so small that declaring with any confidence that one can stand by and watch infants with severe MAS without starting antibiotics is a tough conclusion to come to.  The child though who is born through MSAF and has mild tachypnea as the only symptom I suspect is another story.  I might even argue that the baby who is in need of CPAP could be watched and if they deteriorate have antibiotics started.  As much as I would love to say none of these babies need antibiotics I would have to admit that I would cave once the baby was ventilated.  It is better to provide a couple of days of antibiotics while awaiting blood cultures than to have a patient with sepsis left untreated or at least that is my opinion. The question is what would you do?

AllThingsNeonatal

AllThingsNeonatal

 

A Shocking Change in Position. Postnatal steroids for ALL microprems?

It seems like a sensational title I know but it may not be as far fetched as you may think. The pendulum certainly has swung from the days of liberal post natal dexamethasone use in the 1990s to the near banishment of them from the clinical armamentarium after Keith Barrington published an article entitled The adverse neuro-developmental effects of postnatal steroids in the preterm infant: a systematic review of RCTs in BMC Pediatrics in 2011. This article heralded in the steroid free epoch of the first decade of the new millennium, as anyone caring for preterm infants became fearful of causing lifelong harm from steroid exposure.  Like any scare though, with time fear subsides and people begin asking questions such as; was it the type of steroid, the dose, the duration or the type of patient that put the child at risk of adverse development?  Moreover, when death from respiratory failure is the competing outcome it became difficult to look a parent in the eye when their child was dying and say "no there is nothing more we can do" when steroids were still out there. Over the last decade or so, these questions in part have been studied in at least two important ways.  The first was to ask whether we use a lower dose of dexamethasone for a shorter period to improve pulmonary outcomes without adverse neurodevelopment?  The target population here were babies on their way to developing chronic lung disease as they were ventilated at a week of age.  The main study to answer this question was the DART study. This study used a very low total dose of 8.9 mg/kg of dexamethasone given over ten days.  While the study was stopped due to poor recruitment (it was surely difficult to recruit after the 2001 moratorium on steroids) they did show a benefit towards early extubation.  This was followed up at 2 years with no difference in neurodevelopmental outcomes.  Having said that the study was underpowered to detect any difference so while reassuring it did not prove lack of harm.  Given the lack of evidence showing absolute safety practitioners have continued to use post natal steroids judiciously. The second strategy was to determine whether one could take a prophylactic approach by providing hydrocortisone to preterm infants starting within the first 24 hours to prevent the development of CLD.  The best study to examine this was by Kristi Watterberg in 2004 Prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia: a multicenter trial.  Strangely enough the same issue of early stoppage affected this study as an increased rate of spontaneous gastrointestinal perforation was noted leading to early closure.  The most likely explanation is thought to be the combination of hydrocortisone and indomethacin prophylaxis which some centres were using at the same time. An interesting finding though was that in a subgroup analysis, infants with chorioamnionitis who received hydrocortisone had less incidence of chronic lung disease. (more on this later) Although this of course is subject to the possible bias of digging too deep with secondary analyses there is biologic plausibility here as hydrocortisone could indeed reduce the inflammatory cascade that would no doubt be present with such infants exposed to chorioamnionitis in utero. Has the answer finally come? The DART study at 360 patients was the largest study to date to look at prophylaxis as a strategy.  That is until this past week.  The results of the PREMILOC study have been published which is the long awaited trial examining a total dose of 8.5 mg/kg of hydrocortisone over 10 days.  We can finally see the results of a trial without the complicating prophylactic indomethacin trials interfering with results.  Surprisingly this study was also stopped early (a curse of such trials?!) due to financial reasons this time. Prior to stoppage though they managed to recruit 255 to hydrocortisone and 266 to control groups.  All infants in this study were started on hydrocortisone within 24 hours of age and the primary outcome in this case was survival without BPD at 36 weeks of age. All infants were less than 28 weeks at birth and therefore had a high risk of the combined outcome and despite the study being stopped early there was indeed a better outcome rate in the hydrocortisone group (60% vs 51%).  Another way of looking at this is that to gain one more patient who survived without BPD you needed to treat 12 which is not bad at all. What is additionally interesting are some of the findings in the secondary analyses. The lack of a difference in males may well reflect the biologic disadvantage that us males face overcoming any benefit from the hydrocortisone.  In fact for the females studied the number needed to treat improves to 6 patients only! Short term outcomes of less ventilation are sure to please everyone especially parents.  Lastly, a reduction in PDA ligation is most probably related to an antiprostaglandin effect of steroids and should be cause for joy all around.  Lastly, a tip of the hat to Dr. Watterberg is in order as those infants who were exposed to chorioamnionitis once again show that this is where the real benefit may be. But what about side effects? The rate of NEC is quite high but is so for both groups but otherwise there is nothing much here to worry the reader.  Once and for all we also see that by excluding concurrent treatment with indomethacin or ibuprofen the rate of GI perforation is no different this time around.  Reassuring results indeed, but alas the big side effect, the one that would tip the scale towards us using or abandoning treatment has yet to be presented.  Steroids no doubt can do great things but given the scare from 2001 we will need to see how this cohort of babies fares in the long run. The follow-up is planned for these infants and the authors have done an incredible job of recruiting enough patients to make the results likely believable.  I for one can't wait to see what the future holds. If I was a betting man though I would say this ultra low dose of hydrocortisone may be just the thing to bring this therapy finally into the toolbox of neonatal units worldwide.  We have been looking for the next big thing to help improve outcomes and good old hydrocortisone may be just what the doctor ordered.

AllThingsNeonatal

AllThingsNeonatal

 

Breastfeeding...who says it's not natural?!

I woke up this morning and as I do everyday, scanned the media outlets for news that would be of interest to you the reader.  Most of the time I am searching for items of interest that I hope will get people thinking about ways to improve care but once in awhile I come across something that elicits a strong emotional reaction and today was the day. CNN released the following article today entitled Are there unintended consequences to calling breast-feeding 'natural'? The premise of the article is that by reinforcing that breastfeeding is natural we may hamper initiatives to increase vaccination in many parts of the world and in particular North America I would think.  The idea here is that if we firmly entrench in women's heads that natural is better then this will strengthen the conviction that we should not vaccinate with these "man made" unnatural vaccines.  I am sorry to be dramatic about this but I think the argument is ridiculous and in fact dangerous. The Definition of Natural "existing in nature and not made or caused by people : coming from nature" From the Mirriam Webster dictionary Breastfeeding satisfies this definition pure and simple and there is nothing that anyone should say to suggest otherwise no matter what the motive is.  The shift from formula  to breastfeeding has been predicated on this notion and a plethora of literature on the subject demonstrating reductions in such things as infections of many kinds, diarrhoea, atopic disease in the first year of life as examples.  In my world of premature infants additional reductions in NEC, bloody stools, have been seen and more recently in some cases improved neurodevelopmental outcomes. In this case of irresponsible journalism a better approach if you were wanting to use the natural argument with respect to vaccines is to promote just that. Vaccines are Natural Someone will no doubt challenge me on this  point as it would be a fair comment to say that there are artificial substances added to vaccines but there is no question the organisms that we vaccinate against are natural. Think about this for a moment.  All of the vaccines out there are meant to protect us against organisms that exists in NATURE.  These are all bacteria or viruses that have likely existed on this planet of ours for millions of years.  They are found everywhere and in many cases what we are doing when we give such vaccines are providing parts of or weakened versions of these natural organisms in order for us the human to mount a protective response. This protective response is NATURAL.  If we didn't vaccinate and came across the fully virulent pathogen in NATURE our bodies would do exactly what they do when a vaccine is given to us.  Our immune system would mount a response to the organism and start producing protective antibodies.  Unfortunately in many cases this will be too little too late as the bacteria or virus will cause it's damage before we have a chance to rid ourselves of this natural organism. This is the basis of vaccination.  Allow our bodies a chance to have protection against an organism that we haven't been exposed to yet so that when it comes we have a legion of antibodies just waiting to attach this natural organism. CNN Didn't Get It Right In the article which is based on a paper entitled the Unintended Consequences of Invoking the “Natural” in Breastfeeding Promotion by Jessica Martucci &  Anne Barnhill the authors admit that the number of families that this actually would impact is small.  the question then is why publish this at all.  Steering families away from thinking that breastfeeding is natural is wrong.  Plain and simple. If the goal is to improve vaccination rates, focus on informing the public about how NATURAL vaccinations actually are and don't drag breastfeeding down in order to achieve such goals. Hopefully someone out there linked to CNN will see this as this is one upset blogger at the moment...

AllThingsNeonatal

AllThingsNeonatal

 

Antenatal steroids may well benefit near term infants. Time for a global rethink?

What a hard topic to resist commenting on.  This was all over twitter and the general media this week after the New England Journal published the following paper; Antenatal Betamethasone for Women at Risk for Late Preterm Delivery.  The fact that it is the NEJM publishing such a paper in and of itself suggests this is a top notch study...or does it? In case the idea of giving antenatal steroids after 34 weeks sounds familiar it may be so as I wrote about the use of such an approach prior to elective c-section in a previous post; Not just for preemies anymore? Antenatal steroids for elective c-sections at term. Is there a benefit to giving antenatal steroids from 34 0/7 - 36 5/7 weeks? That is the central question the authors here sought to answer. Would women who had a high risk of delivering during this time period have less risk of a composite primary outcome of treatment in the first 72 hours (the use of continuous positive airway pressure or high-flow nasal cannula for at least 2 hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 hours, extracorporeal membrane oxygenation, or mechanical ventilation) or stillbirth or neonatal death within 72 hours after delivery. On the surface this seems like a very worthwhile set of outcomes to look at and the authors found in the end some pretty remarkable findings in a total of 2827 women randomized to placebo or betamethasone. Looking at the results one sees that the primary outcome showed a significant difference with 2.8% less infants experiencing these conditions. However, when one looks at the details the only contributor to this difference was the need for CPAP or HFNC for >= 2 hours.  A need for over 30% FiO2 for > 4 hours was also not different.  No differences were noted in mechanical ventilation, ECMO, deaths whether stillbirths or neonatal deaths.  Curiously, significant differences for secondary outcomes were seen with incidence of severe respiratory distress, and need for CPAP for over 12 hours. These results are not truly that surprising at least for the primary outcome as if you asked most people working in the field of Neonatology how likely death, need for ECMO or even mechanical ventilation are from 34 - 36 weeks they would tell you not very likely.  The other thing to consider is that the only real significant difference was noted for infants needing CPAP or HFNC for at least 2 hours.  While this would interrupt maternal infant bonding, it wouldn't necessarily mean an admission but rather in some cases observation and then transfer to the mother's room. Is it worth it? To answer this question you need to know the best and worst case scenarios I suppose. Based on the reduction of 2.8%, you would need to treat 35 women with betamethasone to avoid the primary outcome but of course there is a range based on the confidence intervals around this estimate.  The true estimate lies somewhere between 18 - 259 to avoid the outcome.  Having said that, the estimate to avoid severe distress is 25 patients with a range of 16 - 56 which is pretty good value.  In a perfect world I would probably suggest to women that there seems to be a benefit especially if one notes that in this study only 60% of the women received 2 dose of betamethasone so if rates of administration were higher one might expect and even better outcome.  Ah but the world is not perfect.... There is only so much betamethasone to go around. I find it ironic but the same day that this article came across my newsfeed so did a warning that we were about to run out of betamethasone vials in a certain concentration and would need to resort to another manufacturer but that supply may also run out soon as well.  The instructions were to conserve this supply in the hospital for pregnant women. In Canada as reported by the Canadian Neonatal Network in 2010,  38.1% of babies admitted to NICUs were below 34 weeks.  Given that all babies would be admitted to NICUs at this gestational age and below that likely represents the percentage of births in those ages. An additional 31.8% or almost an equal number of babies will be born between 34 0/7 to 37 0/7 weeks meaning that if we were to start treating women who were deemed to be at risk of preterm delivery in that age range we would have a lot of potential women to choose from as these are the exact women in this strata who actually delivered early in Canada. If I am forced to choose whether to give betamethasone to the mothers under 34 weeks or above when the resource we need is in scarce supply I don't think there is much choice at all.  Yes, this article comes from a reputable journal and yes there are some differences some of which are highly significant to consider but at least at this time my suggestion is to save the supply we have the babies who will benefit the most.

AllThingsNeonatal

AllThingsNeonatal

 

All Things Neonatal Anniversary Edition

It is hard to believe but All Things Neonatal is a year old.  When I started this little concept I had no idea what was to come but am delighted with where it has gone.  While the Blog site itself has about 200 followers, the Facebook page is home to nearly 4200 followers with twitter accounting for over 500 more.  What began as a forum for me to get some thoughts off my chest about neonatal topics or articles of interest has morphed into a place to create change.  As I look back over the last year I thought I would update the readers of this page and other social media platforms what the outcome has been for some of the ideas that I have brought forward.  We have implemented some of these suggestions into our own unit practices, so without further ado here are the updates for some (but not all!) of the changes we have introduced. Expanding the Circle of Influence With Neonatal Telehealth March 4, 2015 Articles pertaining to use of Telehealth in all aspects of medicine are becoming commonplace.  Locally we have seen expansion of rural sites that can connect with us and a strong desire by existing sites to connect via telehealth for a variety of reasons.  While the thrust of the program was to deliver advice to rural practitioners and support our level I and II units we have found such support leading to possibilities we had not dreamed of. Initial discussions via telehealth and in person have occurred examining whether such treatments as CPAP stabilization and NG feedings could be done in these sites.  Being able to provide such care will no doubt lead to more stable infants being transported to our site and moreover the possibility of moving the care for infants needing only gavage feeding back to their home communities.  Who knows what the future will hold for us as we also look forward to the hiring of a telehealth coordinator for NICU! A Strategy to Minimize Blood Sampling in ventilated premature and term infants April 13, 2015  This has been one of my favourite topics to write about.  The ability to sample CO2 from an area near the carina has been demonstrated to be accurate and to save pokes in the long run.  Since writing this piece we have tried it on several babies by using a double lumen tube and found the results to be as accurate as described in the Israeli papers.  In practice though, secretions have proved difficult to handle for longer periods of use as they can travel up the sampling lines and damage the filters in the analyzers.  A costly issue to deal with that we are currently trying to solve.  Being able to continuously sample CO2 and adjust ventilation without drawing frequent blood gases is somewhat of a dream for me and we will continue to see how we can go about making this an established practice but there is work to be done! Is it time to ban Cow's Milk Protein from the diet of our high risk NICU population? June 12, 2015 I think most people in Winnipeg would say the answer is yes.  On this front two major positive changes have occurred in the last year in this regard.  The first is that through a generous donation and the blessing of our health region we have been able to expand the use of donor breast milk from < 1250g for a two week period to < 1500g for a one month period.   This wonderful change came about after much effort and was celebrated in December as we not only expanded the eligibility criteria but partnered with the NorthernStar Mother's Milk Bank to provide donor milk to Manitobans (Manitobans Now Able To Support Premature Infants Through Donor Milk Program!).  The other change which the above post also spoke of was the potential to eliminate bovine milk altogether with the use of Prolacta (Human based human milk fortifier).  While we don't have the approval to use the product as traditionally indicated, we have used it as a "rescue" for those patients who demonstrate a clear intolerance of bovine fortifier.  Such patients would traditionally receive inadequate nutrition with no other option available but now several have received such rescue and we look forward to analyzing the results of such a strategy shortly! Winnipeg Hospital About to Start Resuscitating Infants at 23 weeks! September 25, 2015 Without question the most talked about change was the change in threshold for recommending resuscitation from 24 to 23 weeks.  The change took almost a year to roll out and could not have been done without a massive educational rollout that so many people (a special thank you to our nurse educators!) took part in.  Looking back on the year we have now seen several infants at 23 weeks who survived with a small minority dying in the newborn period.  It is too early to look at long term outcomes but I think many of us have been surprised with just how well many of these children have done.  Moreover I believe we may be seeing a "creep effect" at work as the outcomes of infants under 29 weeks have also improved as we developed new guidelines to provide the best care possible to these vulnerable infants.  Antenatal steroid use is up, IVH down and at least from January to September of last year no infants died at HSC under 29 weeks!  I look forward to seeing our results in the future and cannot tell you how impressed I am with how our entire team came together to make this all happen! What's Next? I wanted to share some of the initiatives that came forward or were chronicled on these pages over the last year to show you that this forum is not just a place for my mind to aimlessly wander.  It is a place that can create change; some good, some great and no doubt some that won't take.  It has also been a place where ideas are laid out that have come from afar.  From readers anywhere in the world who ask a question on one of the social media sites that get me thinking!  I have enjoyed the past year and expect I will continue to enjoy what may spring forth from these pages for some time to come.  Thank you for your contributions and I hope you get a little something out of this as well!

AllThingsNeonatal

AllThingsNeonatal

 

Building a better mask for positive pressure ventilation

Ask almost anyone who has worked in the field of Neonatology for some time and they will tell you that babies are not as sick as they once were. We can give a lot of credit to better antenatal steroid use, maternal nutrition and general management during pregnancy.  Additionally, after birth we now rush to place infants on CPAP and achieve adequate expansion of the lungs which in many cases staves off intubation. The downside to our success though is that the opportunities to provide positive pressure ventilation (PPV) and moreover intubation are becoming less and less.  How then do we perform when we are asked to do such procedures on an infrequent basis?  The answer as you might expect is not that well.  Dr. Schmolzer et al studied the ability of people to keep a good seal and found a 29% leak on average with as high as 63% in one patient.  As this was a study in which people were being observed one might think the Hawthorne Effect might artificially decrease the percentage leak compared to real world scenarios when you know you aren't being watched. What is the cause of the leak? Leaks most commonly occur on either side of the nasolabial folds.  Although at least in my experience we educate trainees about this issue it remains a problem.  I would also speculate that at the times when we need to be at our best during an advanced resuscitation involving chest compressions we may well function at our worst.  This is the effect of the adrenalin rushing through our system as our sympathetic system turns into overdrive.  The question therefore is one of getting around human error in particular when we need to minimize such inefficiency the most. The Solution? If the masks are prone to leaking and with it the ability to properly ventilate compromised, how could we minimize such human error.  The answer may lie in what I consider to be an ingenious way to apply a mask. The concept and it is just that at the moment is to use suction to apply the mask to the face without risk of leak.  Lorenz L et al have just published a proof of concept study utilizing a mannequin with a "seal skin" layer applied to the face to simulate human skin.  The article is entitled A new suction mask to reduce leak during neonatal resuscitation: a manikin study. In this study, the mask was applied to the face of the mannequin and 100 cm H2O pressure was applied through a side port on the mask.  There is an inner and outer ring such that the internal 41 mm diameter mask is surrounded by a double wall in which the suction is applied to the space between the two walls leading to the mask seating itself firmly against the face.  The authors then studied the amount of leak found when using a Neopuff set to deliver 40 - 60 breaths per minute at pressures of 25/5.  For this study 60 courses were tested. How did it do compared to PPV through a traditional mask? As you might expect (since you can feel my excitement!) it did very well. The average leaks using a conventional approach were quite good at 12.1% but the suction mask was only 0.7% leak.  Importantly the ranges were quite different.   PPV through a conventional mask had a range of 0.6 - 39% leak while with the suction version it was 0.2 - 4.6%.  These results were statistically different. What does the future hold? As mentioned this study is what one would consider a proof of concept study.  We do not know how this would fare in the real world and that of course is the next step.  In terms of harm, the authors did note that when applied to the forearm of an adult it caused some mild redness from the suction that vanished quickly on breaking of the seal but we do not know if there could be greater harm in a newborn in particular one who is quite small.  Such testing will be needed as part of any further study. Having said that I think this rethink of the mask for PPV could be transformative to those who perform neonatal resuscitation infrequently.  If this mask is found not only to be effective in a clinical trial but safe as well I would suggest a change to this type of mask could quite literally be life saving.  Placed in the hands of those who are inexperienced in keeping a seal, PPV would become much more effective and in particular for rural sites the infants being transported in much more stable than some are at present. Keep your eyes peeled for future work using this mask.  Something tells me if it proves to be efficacious outside of a seal skin covered mannequin, your toolkit for providing NRP may be in for a change.

AllThingsNeonatal

AllThingsNeonatal

 

Non-sterile gloves to reduce NICU infections. Back to the Future?

I don't know about you but I have deeply rooted memories from the 1990s of donning a yellow gown and gloves before examining each and every patient on my list before rounds.  This was done as we firmly believed such precautions were needed to prevent the spread of infections in the NICU.  As time went on though the gowns were removed and not long after so went the gloves as priority was placed on performance of good hand hygiene to reduce rates of infection in our units. You can imagine that after having it entrenched in my mind that hand hygiene was the key to success that I would find it surprising to see a paper published a few months ago suggesting that the use of gloves after hand hygiene may offer a benefit after all.  Kaufman DA et al published Nonsterile glove use in addition to hand hygiene to prevent late-onset infection in preterm infants: randomized clinical trial and given it's challenge to a practice that is at least two decades old I thought it may be worth sharing with you the reader. Essentially the authors hypothesized that the use of non-sterile gloves after performing hand hygiene (compared to hand hygiene alone) would reduce late-onset invasive infection (>72 hours after birth), defined as 1 or more episodes per patient of a BSI, urinary tract infection,meningitis, and/orNEC associated with clinical signs and symptoms of infection and treated with antimicrobials.  When determining the size of study needed, they used a baseline incidence of 60% and looked to find a 25% reduction in their outcome.  Unfortunately for them (although very fortunate for their patients, the incidence of LOS in the experimental arm was 32% with a 45% incidence in the control group (hand hygiene alone).  What does this mean when your expected rate is higher than your observed?  In short you need more patients to show a difference and indeed they failed to show a significant difference between the two groups. They did however find a difference in gram positive infections being 15 vs 32% p=0.03 and seem to take some comfort in this finding.  If you were to give the paper a quick read you might be impressed with the finding and might even shrug your shoulders and say the common expression "Can't hurt but might help"  Maybe we should adopt this? Not so Fast There is a significant potential source of error here that needs to be addressed.  The definition of a proven blood stream infection as per the CDC is two positive cultures for the same organism.  In this study only one culture was required to be positive so the potential for diagnostic error is high.  In our own centre although unpublished we have noted since adopting a mandatory two culture collection approach for LOS that there have been a significant number of occasions where one culture was noted to be positive and the other negative.  Antibiotics in these cases have been stopped (for gram positive organisms) after 48 hours without consequence.  In this study however the findings of increased rates of positive cultures in the hand hygiene only group is heavily influenced by the presence of only one positive culture as is seen in this table. When looking at the numbers of times there were greater than or equal to 2 positive cultures in the CoNS group one sees the vast majority were only based on one culture.  Furthermore, of the 20 infections in the hand hygiene only group, 19 were gram positve CoNS of which only 4 had more than one culture.  Based on this finding and the lack of any other significant difference in infectious outcomes the proof that gloves add anything to reducing infection rates is tough to argue. Could Gloves Actually Make Things Worse? Several studies have actually indicated that wearing gloves reduces hand hygiene compliance.  One such study although in adults "The dirty hand in the latex glove": a study of hand hygiene compliance when gloves are worn. suggests that this is indeed the case with a 9% decrease in proper hand hygiene when gloves were worn.  Others such as Flores in 2006 found similar poor perfomance when gloves were used Healthcare workers' compliance with glove use and the effect of glove use on hand hygiene.  I would speculate that although we all want to do what is best for our patients there may be a psychological trick being played here.  Perhaps knowing we will cover up with gloves leads people to take shortcuts on hand hygiene as they subconciously think they will be covered anyway.  Never mind that the "dirty" hand touches the gloves they will put on making proper hand hygiene a must. Conclusion It certainly was a shock to see such a paper as I saw flashes of my past yellow gowned self coming back to haunt me.  Based on my take of this paper however I would say that at least for the time being I will take my time, wash my hands before and after every patient encounter and keep the gloves around for handling those yet unbathed newborns.  Spend your energy where it counts and that is ensuring your hands are properly cleaned before touching your patient or lines.

AllThingsNeonatal

AllThingsNeonatal

 

The Eyes Have It. No Not Really

Every now and then I come across an instance when I discover that something that I have known for some time truly is not as well appreciated as I might think. Twice in my career I have come across the following situation which has been generalized to eliminate any specific details about a patient.  In essence this is a fictional story but the conclusions are quite real. Case of the Flat Baby A mother arrives at the hospital with severe abdominal pain and in short order is diagnosed with a likely abruption at 26 weeks gestational age. Fetal monitors are attached and reveal a significant fetal bradycardia with a prolonged period of minutes below 100 and sometimes below 60 beats per minute.  She is rushed to the OR where an emergency c-section is performed. A live born infant is handed to the resuscitation team after cord clamping is stopped at 30 seconds due to significant cyanosis and no respirations.  After placing the infant in a polyethylene wrap and performing the initial steps of ventilation there is no respiratory effort and the baby is given PPV.  After no heart rate is noted chest compressions commence followed by intubation and then epinephrine when a heart rate while detected remains below 60.  The team gives a bolus of saline followed by another round of epinephrine and by 10 minutes a pulse of 80 BPM is detected.  While a pulse is present it remains borderline and the baby shows no sign of any respiratory efforts. The care providers at this point have a decision to make about continuing resuscitative efforts or not.  One of the team members performs a physical exam at this stage and notes that the pupils are unresponsive to light with a 3 mm pupillary diameter.  The team questions whether based on this finding irreversible neurological damage has occurred. Pupillary Reactions in Preterm Infants It turns out that much like many organs in the body which have yet to fully mature the same applies to the eye or more specifically in this case the pupil. Robinson studied 50 preterm infants in 1990 and noted that none of the infants under 30 weeks gestational age demonstrated any reaction to light shone in the eye.  After 30 weeks the infants gradually realized this function until by 35 weeks all infants had attained this pupillary reaction to light. Isenberg in the same year when examining 30 preterm infants under 30 weeks noted that in addition to the lack of pupillary constriction to light, as the gestational age decreased the pupillary diameter enlarged.  The youngest infants in this study at 26 weeks had a mean pupillary diameter of 4.7 mm while by 29 weeks this number decreased to 2.9 mm.  This means that the smaller the infant the larger the pupillary size and given that these are also the highest risk infants one can see how the appearance of a "fixed and dilated pupil" could lead one down the wrong path. Conclusion Deciding when to stop a resuscitation is never an easy decision.  Add to this as I recently wrote, even after 10 minutes of resuscitation outcomes may not be as bad as we have thought; Apgar score of 0 at 10 minutes: Why the new NRP recommendations missed the mark.  What I can say and obviously was the main thrust of this piece is that at least when you are resuscitating an infant  < 30 weeks gestational age, leave the eyes out of the decision.  The eyes in this case "do not have it".

AllThingsNeonatal

AllThingsNeonatal

 

Is there really a place for standard phototherapy in the NICU anymore?

I have been mulling over this piece for some time.  In my own practice I have long questioned the role for standard phototherapy (the equivalent of a single light source) vs intensive phototherapy (delivering >30 microwatts/cm2/nm and usually two light sources) when treating jaundice for all patients. I have bolded that last part to emphasize that I am not just talking about newborns with severe hyperbilirubinemia but rather all infants with treatable jaundice based on local treatment curves such as shown in the CPS and AAP statements.  When newborns are only 30 - 50 micromol/L above the treatment threshold as an example, I will see standard phototherapy ordered or after initiating treatment with intensive phototherapy as the level approaches no treatment required you will see people switch to standard phototherapy again.  Why is that and does it make sense? The rationale for using less intensive phototherapy has been to minimize side effects.  Historically, these were retinal damage (hence the eye covers), electrolyte disturbances, increased insensible water loss and occasionally rashes.  I use the word historically as they for the most part are no longer relevant today provided a narrow spectrum LED light source is utilized which is the technology used in most modern phototherapy light sources now.  Backing up this claim, in 2008 Dr. Maisels, showed that in preterm infants receiving LED based light there were no increases in transepidermal water loss.  By limiting the wavelength of light emitted to 430  - 490 nm and avoiding the infrared wavelengths.  Whether the concern exists with respect to retinal effects is tough to say for sure so continued precautions with eye covers are recommended. Go Big or Go Home If there is little harm to phototherapy then is there a reason to use more?  The effectiveness of phototherapy is generally based on three things.  The first is the proximity of the light source to the patient (< 15 cm is ideal), the second is the intensity of the lamp and the third is the surface area covered.  If you are using a single focused spot and covering only 15- 20% of the body you are missing out on a lot of skin that could be helping to lower an infants bilirubin more rapidly.  As I see it, if there is little harm in giving phototherapy and the rate of bilirubin decline is faster with better phototherapy, why would you use anything less than intensive using two light sources?  Also from a developmental care point of view, less time under the lights means more time for skin to skin and that is always a good thing. Phototherapy and DNA damage What prompted me to write this piece actually was the following paper Jaundice, phototherapy and DNA damage in full-term neonates by Ramy N et al from November of 2015.    In this paper the authors used a validated measure of DNA damage and assessed infants both before and after phototherapy.  Thirty six newborns with jaundice were compared to 30 controls.  The results are shown in the following figure. Figure B demonstrates that prior to initiation of phototherapy the extent of DNA damage in tested cells is no different whether you are jaundiced or not.  In essence bilirubin is not toxic to cells which also makes sense knowing that bilirubin has antioxidant properties and hence one would think it might be protective against DNA damage.  It is figure C and D that provide the most interesting information.  Figure C demonstrates that phototherapy (conventional and intensive groups combined) leads to an increase in DNA damage.  Figure D is important in that it illustrates that comparing conventional and intensive phototherapy groups there is no difference in rates of DNA damage.  This would indicate that more intensive phototherapy is not hazardous to cells. What was noted in the end though is what is most important here.  As expected the duration of phototherapy differed between the two strategies.  Infants in the conventional group were under lights for 62.2 ± 23.02 hrs vs 41.3 ± 22.9 hrs, P = 0.005 in the intensive group.  When the authors analyzed the relationship between DNA damage and length of phototherapy there was a statistically significant relationship between the two. In summary then Intensive phototherapy is more effective than conventional at reducing levels of jaundice Phototherapy is associated with minimal clinical side effects whether intensive or conventional. Infants receiving conventional phototherapy require longer courses of treatment. Longer courses are associated with greater levels of DNA damage. The significance of this DNA damage is unknown based on this study but in principal avoiding such injury may be a wise thing to do. One last benefit - less needle pokes and shorter lengths of stay! If an infant spends an average of one less day under phototherapy lights do not underestimate the added benefit with respect to avoiding needle pokes.  Typically such infants receive one poke a day to "check how the decline is going".  Shortening the course of phototherapy may translate into one or two less pokes or more and that is definitely a good thing! Lastly I will leave you with a tip from my own practice which I have found very useful to eliminate at least one poke.  When phototherapy is effective and the bilirubin is coming down (and is close to the threshold for stopping but not quite there yet) it is common for people on rounds to order another bilirubin for the morning and continue phototherapy until that result.  The result comes back the following morning and the practitioner orders a follow-up bilirubin  for the following day to check for the "rebound". An alternative strategy is to keep the infant on phototherapy overnight and rather than checking on the bilirubin in the morning just stop the phototherapy on rounds.  Eight hours later check the bilirubin and if it is below the threshold for treatment send the infant home.  You avoid an overnight stay and instead of poking twice in two days do it all in one. Whether you take this advice or not is up to you but if all that comes from this post is a decrease in the general fear of intensive phototherapy I may have gotten somewhere and the DNA of many babies out there will thank you!

AllThingsNeonatal

AllThingsNeonatal

 

Is Cannabis To Blame For The Rise In Rates of Gastroschisis?

Gastroschisis, a condition in which the bowel herniates out of the abdomen during fetal development, is on the rise.  The rising incidence which occurs about 2000 times a year in the US caught the interest of CNN in a piece on their site this week.  Canada is no different with rates seeming to increase steadily over the last decade or so and many of us who care for these infants are left scratching our heads as to why. What Causes Gastroschisis to Occur Interestingly, the site of herniation is almost always to the right of the umbilicus and the most prevalent theory out there is that a vascular insult during fetal development leads to a weakening in the developing abdominal wall.  The bowel then herniates through this insufficiency.  What then could could explain the near universal occurence on the right? The Vascular Disruption Theory. You may not have known this but the embryo begins life with two umbilical veins and two omphalomesenteric arteries. At about one month of gestation the right umbilical vein involutes leaving you with only one umbilical vein.  In this disruption theory, the vein involution occurs early leading to ischemia in the territory that eventually causes weakness in the abdominal wall to the right of the umbilicus.  On the arterial side the  left omphalomesenteric artery also involutes, with the right one becoming the superior mesenteric artery. It could be that disruption of this process also leads to gastroschisis. Risk Factors For Gastroschisis If you work in the field of Neonatology one of the first surgical truisms you learn in that gastroschisis occurs most commonly among very young mothers.  Broadly speaking, gastroschisis also tends to cluster among women of low socioeconomic status (SES) and all that goes with that designation.  Poor diet, education and drug use are intimately linked with the condition but in the end the proxy may be low SES.  When it comes to drug use it is the drugs that have vasoactive properties that are most often associated with heightened risk for the condition.  Such drugs include, amphetamines, cocaine, as well as ibuprofen, acetaminophen. Finally, smoking likely secondary to nicotine and other vasoactive chemicals which may affect placental circulation also finds itself closely linked with development of the condition. In terms of quantifying the risk, Draper et al performed a case control study to quantify the risk of such use.  The interesting aspect of their study is that they confirmed drug use through analysis of maternal hair to demonstrate exposure.  Previous studies relied on maternal interviews to disclose which drugs had been used in pregnancy which may be prone to omission.  They found the following 1) Any recreational drug  - odds ratio (OR) 2.2, 95% confidence interval (CI): 1.2, 4.3) 2) Vasoconstrictive recreational drugs (cocaine, amphetamines & ecstasy) (OR 3.3, 95% CI: 1.0, 10.5) 3) Aspirin use (OR 20.4, 95% CI: 2.2, 191.5) 4) Cigarette smoking (OR 1.7, 95% CI: 1.1, 2.6) So drugs from a variety of classes seem to increase risk for the condition.  Could a rise in drug use in young women account for the increase then? Trends in Drug Use The National Institute of Drug Abuse provides some interesting data in this regard.  The following curve demonstrates the trend in drug use in the US over a period that has seen the incidence of gastroschisis rise almost two fold. The data collected on this site is obtained from surveys and as such is prone to the same errors that any survey has namely how sure are we that what is disclosed is the reality?  Having said that it is clear that in terms of illicit drug use, cannabis accounts for the majority of the rise in use over the last decade. Furthermore, it is well known that cannabis is a "gateway drug" and the same site indicates that over 50% of new users are under the age of 18 and of these new users the drug of choice is marijuana. Looking at pain relievers such as tylenol and ibuprofen there is no data to suggest at least in the very young group of mothers consumption of these medications has been on the rise.  Clearly we have a problem with over prescription of opioid analgesics in pregnancy but to my knowledge these have not been associated with the development of gastroschisis. What about smoking in teens? As the graph from the CDC below demonstrates, smoking is at an all time low among US high school students.  These same students are the ones having babies with gastroschisis so at first glance this doesn't seem to be a probable cause.  Are rates among low SES students showing the same decline?   A shown in this link, rates even among these groups do seem to be declining as well even though level of education does show correlations with higher prevalence of smokers. Could Increased Cannabis Use Be The Culprit?   Almost twenty years ago a surgeon mentioned to me on a rotation during my residency that he had noted an association between marijuana use and gastroschisis.  While I don't believe this was ever published I have to admit it stuck as if it were gospel.  Some years later in another conversation about a patient with gastroschisis he said with a smile that after all these years he believes the link is an association.  Young mothers use more marijuana and they also have more babies with gastroschisis.  What we have here now though is something a little different.  The question at hand is why is gastroschisis on the rise in the same group? Is it cannabis?  It just might be but this will need some further work to tease out.   If gastroschisis is caused by a vascular phenomenon and the only real rise in drug use affecting perfusion is that associated with cannabis, it might be.  On the other hand this could just be another association that will not stand the test of time.  I don't have it in for cannabis and in fact believe it could one day be quite useful in Neonatology as I have written before in Marijuana Coming Soon To An NICU Near You! What goes around comes around as the saying goes and as my colleague nears the end of his long and storied career that in the end his original observation would be proven true. I have no wish for cannabis to be linked to the increase in gastroschisis but a part of me would love to see my colleague proven right after all these years.  Stay tuned!

AllThingsNeonatal

AllThingsNeonatal

 

High frequency nasal ventilation: Ready for prime time?

I will admit it.  I resist change at times just like many others.  This may come as a surprise to some of you who have worked with me and accused me of bringing too much change at times to the units.  The truth though is that when one understands something and is enthusiastic about implementation the change does not seem so difficult.  When it isn't your idea though we may find ourselves a little uneasy about adopting this unfamiliar practice. Such has been my experience with nasal HFOV.  It is a strategy that has been around for over five years but has seen slow adoption among centres in Canada and has trickled into practice in Winnipeg on a few occasions.  In each occasion when I have been asked about either continuing or perhaps starting this therapy I have shrugged my shoulders and confessed my inexperience with the modality.  Sure I have used HFOV through an ETT but through prongs or a mask?!  How would it work?  Could it cause harm?  What would the actual indications be?  How would our in house physicians and NNPs respond to abnormal gases overnight even if I felt comfortable with using it?  These sorts of questions have led to virtual inertia in my acceptance of the strategy. Before I go on it would be good to see an example of how it is set up.  The MedinCNO device is capable of delivering such non-invasive HFOV and can be seen in this short video.           One could use the strategy either prophylactically to extubate an infant or as rescue to prevent reintubation if trials of either CPAP or NIPPV were unsuccessful.  HFOV is known to be very effective at clearing CO2 when used through an ETT so perhaps nasal application could also lower pCO2 and achieve a similar effect.  This was tested using a neonatal lung simulator by Mukeji A et al Nasal high-frequency oscillation for lung carbon dioxide clearance in the newborn.  In this study CO2 was introduced into the manequin and the amount of exhaled CO2 determined while on CPAP, NIPPV and nasal HFOV.  Interestingly during CPAP no exhaled CO2 could be detected while CO2 clearance occurred during NIPPV and nasal HFOV although it was three-fold greater with HFOV.  In theory then CO2 clearance would appear to be better so in the case of ventilatory failure as evidenced by CO2 retention this modality would seem to win out. Clinical Evidence for Use There is one RCT in term infants with TTN to support the practice while the rest are unblinded case series with no controls. Four Canadian NICUs recently described their experience however using a retrospective analysis.  Included were 79 instances of HFOV distributed as follows; 73% utilized as rescue from another mode and in 27% used as the primary mode for extubation.  The outcomes are shown in the table: In 45% of cases the patients needed  intubation after first trialing CPAP or NIPPV while in 33% of cases following extubation the infants needed replacement of the endotracheal tube.  The numbers here are small so it is difficult to truly compare them to other studies with confidence but reintubation rates of 40-44% have been noted recently when using NIPPV or CPAP so the numbers are at least consistent. One aspect though that caught my eye was the duration of use for HFOV across these 79 patients.  The median use was 57 hours with the longest duration being just over 400 hours.  It would seem that the use of this modality for the most part is as a bridge to something else.  The median duration of 2.5 days is much shorter than the weeks that some of our smallest infants remain on CPAP/NIPPV for.  Whether for rescue or prophylaxis this is not a long term option. Another point worth noting though is the question of whether it is the pressure or oscillatory wave that is leading to success.  As the authors note, there were a wide range in applications of MAP, delta P and frequency. MAP ranges from 8 - 24 cm H2O while frequency from 6 - 14 hz and amplitude varied widely depending on the device used but was as high as 100%.  While high MAP has been used invasively though an ETT I can't help but wonder if in some cases the real benefit was the high MAP.  What would happen for example if the centres had simply raised the CPAP to 10, 12 or even higher? In the end it would seem that in principal it is an effective therapy that may be able to remove CO2 more efficiently than the other modes.  What we don't have are RCTs in the smallest babies comparing HFOV to NIPPV or CPAP with adequate power to detect differences.  I suspect these will come soon enough but what do we do in the meantime?   The main reservation I have has to do with safety.  We truly have little if any data on this without proper trials to ease such worry.  When a patient is in front of us though and is failing CPAP or NIPPV what are we to do?  Should we intubate or trial this modality based on the evidence thus far? I might be tempted to trial HFOV in this circumstance but as with any new therapy we need education for all staff.  Everyone caring for our infants need to understand what they are using and how to respond based on clinical findings.  This is the real issue with safety that I see and until such time that we have widespread education across RRT, nursing and medicine I would suggest we use this with trepidation.  This is not a rejection of the modality in the least but rather a call to come together as a team and see how implement this in such a way that will provide direction to caregivers, provide a consistent approach with respect to length of use, indications and when to change direction entirely.  Time to call a meeting of the minds I think.

AllThingsNeonatal

AllThingsNeonatal

 

Advice for Parents Regarding Hemangiomas: Time to change our approach in Pediatrics?

The story is typical.  A family notices a small red spot in the weeks following delivery which enlarges over the next month.  They present to their family doctor or Pediatrician who identifies the most common skin lesion in childhood; a hemangioma affecting about 3-10% of all children depending on the population observed.  As a resident I was given the following advice regarding hemangiomas; "As long as the hemangioma is not of cosmetic concern, sight threatening, multiple in number or causing anemia or thrombocytopenia watchful waiting is recommended."  Furthermore I recall the following general advice that while they tend to enlarge over the first year of life, 40% are gone by 4 years, 60% by 6 years and 90% by 9 years.  After my training I started a practice passing along the same advice to the infants I now cared for. Then something happened similar to the serendipitous discovery of penicillin.  In 2008, Leaute-Labreze et al published a case report in which they described a child being treated for a facial hemangioma with corticosteroids.  Unfortunately the hemangioma did not respond to treatment but rather led to a cardiomyopathy requiring treatment with propranolol. Curiously the hemangioma demonstrated significant regression on propranolol.  The results of this case report prompted further treatments with propranolol in an unblinded fashion.  Since this time propranolol and more recently topical Timolol (sample size 41) have been studied both in observational and small randomized controlled trials.  Propranolol while effective has potential side effects such as hypotension, bradycardia and bronchospasm which has limited it's widespread application except for those patients with either large, sight threatening or multiple hemangiomas. Topical timolol in the RCT above was demonstrated to be safe and when given locally, free of such side effects making it a seemingly ideal treatment for smaller hemangiomas that may have some cosmetic concerns later in life as they regress. That being said, the time of onset for regression was noted to be after 12-16 weeks of therapy and the target they aimed for was a reduction of >5% which is certainly modest.  While only a small improvement it was seen 60% of the time in the treatment group and 11% in the placebo arm. From personal experience I have used topical Timolol with patients in the NICU with varying success but in some cases the results were quite impressive.  Looking at the RCT by Chan, timolol was only applied to those hemangiomas that were small and deemed unsuitable for treatment with propranolol. This leaves us with the question; what does one use if anything for larger hemangiomas which traditionally don't fit into the category of needing treatment vs patient observation.  Secondly, is it wise to systematically treat all larger hemangiomas with propranolol as outpatients, given the potential severity of the side effects, some of which may be life threatening. This past week in the New England Journal of Medicine we have come full circle as Leaute-Labreze et all have published a large prospective RCT http://bit.ly/1ACqn2Cto determine the optimal dose and duration of propranolol for treatment of hemangiomas requiring systemic treatment. The number of patients enrolled in this study was 456 which makes it the largest study to date in this field.  This study sought to determine whether 1 mg/kg/day vs 3 mg/kg/day divided twice a day for 3 or 6 months would provide the best resolution without unacceptable side effects.  Eligible patients were between 1-5 months of age with a proliferating hemangioma and were treated for either 3 or 6 months depending on which arm of the study they were on. The results of this trial were striking and found that the best balance of benefit and risk was with 3 mg/kg/day for 6 months and is shown below graphically compared to placebo. This difference translates into a number need to treat to cause regression = 1.7 or rounded up 2.  For every two patients that you treat with propranolol you will cause one hemangioma to regress.  Try finding a therapeutic benefit like that in another trial! But what about safety?  Side effects were rare compared to placebo but not negligible. The most common side effect was diarrhea and with respect to life threatening adverse effects the only one really noted was bradycardia but in a patient with enterocolitis.  My take on this treatment is that it appears to have great impact with little downside! How do we apply these results though to "real life" situations.  We now have as I see it a "one-two punch".  Hemangiomas that are deemed to require no systemic treatment can be treated with a safe topical drop that has been used for years for glaucoma patients.  Patients with larger more significant hemangiomas may be treated with a highly efficacious treatment that may have very few side effects. The downside of systemic therapy at least in Winnipeg is that treatment with propranolol generally requires a hospital admission at the start of treatment to monitor for side effects that would be considered life threatening.  With an incidence of 5% of children it would be impractical to admit 600 children a year for such treatment based on an estimated 12000 births in the region a year. I do believe the time is upon us for change though.  As I see it, gone are the days where we tell parents that we will see what develops when their child has a small hemangioma.  If you have a willing parent who is concerned about the hemangioma and it is < 1.5 cm in size I believe topical Timolol should be offered to the family for a period of 6 months treatment.  Anything larger than that would merit treatment with propranolol.  Nine years is potentially a very long time to wait for a lesion to regress and potentially leave a scar or telangiectasia behind.  If we can do something about it now with such a high rate of success and minimal risk to the patient, why wait? My advice to you if you either have a child with a hemangioma or know someone else with one is to have them ask their doctor whether Timolol or Propranolol would be right for them.  Given these findings I know my practice will change.

AllThingsNeonatal

AllThingsNeonatal

 

Giving surfactant through an LMA. Time to ditch the endotracheal tube?

In the spirit of full disclosure I have to admit I have never placed a laryngeal mask airway (LMA) in a newborn of any gestational age.  I have played with them in simulated environments and on many occasion mentioned that they are a great alternative to an ETT especially in those situations where intubation may not be possible due to the skill of the provider or the difficulty of the airway in the setting of micrognathia for example. In recent years though we have heard of examples of surfactant delivery via these same devices although typically these were only case reports. More recently a small randomized study of 26 infants by Attridge et al demonstrated in the group randomized to surfactant administration through an LMA that oxygen requirements were reduced after dosing.  This small pilot provides sufficient evidence to show that it is possible to provide surfactant and that at least some gets into the airway of the newborn.  This proof of concept though while interesting, did not answer the question of whether such delivery of surfactant would be the same or better than through an ETT.  As readers of my blog posts know, my usual stance on things is that the less invasive the better and as I look through the literature, I am drawn to concepts such as this to see if they can be added to our toolbox of non or less invasive strategies in the newborn. A Minimally Invasive Technique For The Masses? This past month, a small study by Pinheiro et al sought to answer this question by using 61 newborns between 29 0/7 - 36 6/7 weeks and greater than 1000g and randomizing them to either surfactant via the INSURE technique or LMA.  I cannot stress enough so will get it out of the way at the start that this strategy is not for those <1000g as the LMA is not designed to fit them properly and the results (to be shown) should not be generalized to this population. Furthermore then study included only those infants who needed surfactant between 4 - 48 hours of age, were on CPAP of at least 5 cm H2O and were receiving FiO2 between 30 - 60%.  All infants given surfactant via the insure technique were premedicated with atropine and morphine while those having an LMA received atropine only.  The primary outcome of the study was need for subsequent intubation or naloxone within 1 hour of surfactant administration.  The study was stopped early after an interim analysis (done as the fellow involved was finishing their fellowship - on a side note I find this an odd reason to stop) demonstrated better outcomes in the group randomized to the LMA. Before we get into the results let's address the possible shortcomings of the study as they might already be bouncing around your heads.  This study could not be blinded and therefore there could be a significant bias to the results.  The authors did have predetermined criteria for reintubation and although not presented, indicate that those participating stuck to these criteria so we may have to acknowledge they did the best they could here.  Secondly the study did not reach their numbers for enrolment based on their power calculation.  This may be ok though as they found a difference which is significant.  If they had found no difference I don't think I would be even writing this entry!  Lastly this study used a dose of surfactant at 3 mL/kg.  How well would this work with the formulation that we use BLES that requires 5 mL/kg? What were the results? Intervention Failure LMA Group ETT group p Any failure 9 (30%) 23(77%) <0.001 Early failure 1 (3%) 20 (67%) <0.001 Late failure 8 (27%) 3 (10%) 0.181 What do these results tell us?  The majority of failures occurred within an hour of delivery of surfactant in the ETT group?  How does this make any sense?  Gastric aspirates for those in the LMA group but not the INSURE group suggest some surfactant missed the lung in the former so one would think the intubation group should have received more surfactant overall however it would appear to be the premedication.  The rate of needing surfactant afterwards is no different and in fact there is a trend to needing reintubation more often in the LMA group but the study was likely underpowered to detect this difference.  Only two patients were given naloxone to reverse the respiratory depressive effects of morphine in those given the INSURE technique so I can't help but speculate that if this practice was more frequent many of the reintubations might have been avoided.  This group was quite aggressive in sticking to the concept of INSURE as they aimed to extubate following surfactant after 5 - 15 minutes.  I am a strong advocate of providing RSI to those being electively intubated but if the goal is to extubate quickly then I believe one must be ready to administer naloxone soon after extubation if signs of respiratory depression are present and this did not happen effectively in this study.  Some may argue those getting the INSURE technique should not be given any premedication at all but that is a debate that will go on for years I am sure but they may have a valid point given this data. Importantly complications following either procedure were minimal and no different in either group. Where do we go from here? Despite some of the points above I think this study could prove to be important for several reasons.  I think it demonstrates that in larger preterm infants it is possible to avoid any mechanical ventilation and still administer surfactant.  Many studies using the minimally invasive surfactant treatment (MIST) approach have been done but these still require the skill of laryngoscopy which takes a fair bit of skill to master.  The LMA on the other hand is quite easy to place and is a skill that can be taught widely.  Secondly, we know that even a brief period of over distension from PPV can be harmful to the lung therefore a strategy which avoids intubation and direct pressure to the lung may offer some longer term benefit although again this was not the study to demonstrate that. Lastly, I see this as a strategy to look at in more rural locations where access to highly skilled level III care may not be readily available.  We routinely field calls from rural sites with preterm infants born with RDS and the health care provider either is unable to intubate or is reluctant to try in favour of using high flow oxygen via mask.  Many do not have CPAP either to support such infants so by the time our Neonatal Transport team arrives the RDS is quite significant.  Why not try surfactant through the LMA?  If it is poorly seated over the airway and the dose goes into the stomach I don't see them being in any worse shape than if they waited for the team to arrive.  If some or all of the dose gets in though there could be real benefit. Might this be right for your centre?  As we think about outreach education and NRP I think this may well become a strong reason to spend a little more time on LMA training.  We may be on to something!  

AllThingsNeonatal

AllThingsNeonatal

 

A New Years Wish. Are We Up to It?

I have been at this writing thing for almost a year and as I was approaching the end of 2015 my thoughts turned to asking myself what I have learned.  There have been so many posts, in fact so many between the blog and Facebook posts that I have truly lost count.  Having said that the posts have generally fallen into two dominant categories; those promoting a therapy or diagnostic tool and those suggesting that we should avoid certain practices. If I had to have one wish though it would be that we could improve upon our diagnostic accuracy when it comes to treating suspected infections in the newborn.  As health care providers we have an extremely loud inner voice trying to tell us to minimize risk when it comes to missing a true bacterial infection.  On the other hand so much evidence has come forth in the last few years demonstrating that prolonging antibiotics beyond 48 hours is not just unwise in the absence of true infection but can be dangerous.  Increased rates of necrotizing enterocolitis is just one such example but other concerns due to interfering with the newborn microbiome have arisen in more recent years.  What follows are some general thoughts on septic workups that may help you (and myself in my own practice) as we move ahead into the New Year and may we cause less harm if we consider these. The Role of Paired Blood Cultures Although not published by our centre yet, we adopted this strategy for late onset sepsis a couple years back and have seen a significant reduction in work-ups deemed as true infections since adoption.  While the temptation to do only one blood culture is strong as we have a desire to minimize skin breaks consider how many more there will be if you do one culture and get a CONS organism back.  There will be several IV starts, perhaps a central line, repeat cultures etc.  If you had done two at the start and one was positive and the other negative you could avoid the whole mess as it was a contaminant from the start.  On my list of do no harms I think this may have the greatest benefit. The Chest X-Ray Can Be Your Friend While I am not a fan of routine chest x-rays I do believe that if you are prepared to diagnose an opacification on a chest x-ray as being due to a pneumonia (VAP or in those non-ventilated) that you need to follow this up with a repeat x-ray 24 - 48 hours later.  If the opacity is gone it was atelectasis as a true pneumonia will not clear that easily. Well worth the radiation exposure I say. If You Are Going To Do a Work-up Make It A Complete One We hear often in rounds the morning after a septic work-up that the baby was too sick to have an LP and that we can just check the CSF if the blood is positive.  There are two significant problems to this approach.  The first which is a significant concern is that in a recent study of patients with GBS meningitis, 20% of those who had GBS in the CSF had a negative blood culture.  Think about that one clearly... relying on a positive culture to decide to continue antibiotics may lead to partially treated GBS meningitis when you discontinue the antibiotics prematurely.  Not a good thing.  The second issue is that infants with true meningitis can have relatively low CSF WBC counts and may drift lower with treatment. Garges et al in a review of 95 neonates with true meninigits found that CSF WBC counts >21 cells per mm3 had a sensitivity of 79% and specificity at 81%.   This means that in those with true meningitis 19% of the time the WBC counts would be below 21 leading to the false impression that the CSF was "fine".  If antibiotics were effective it could well be by 48 hours that the negative CSF culture you find would incorrectly lead you to stop antibiotics.  Message:  Do the CSF sampling at the time of the septic work-up whenever possible. If We Aren't Prepared To Do a Supra Pubic Aspirate Should We Not Collect Urine At All? This provocative question was asked by a colleague last week and is based on the results of a study which was the topic of the following post: Bladder Catherterizations for UTI: Causing more harm than good?  The gist of it is that it would appear that in many cases the results of a catheter obtained urine cannot be trusted.  If that is the case then are we ultimately treating infections that don't actually exist when the only positive culture is from a urine.  I believe using point of care ultrasound to obtain specimens from a SPA will be the way to go but in the meantime how do we address the question of whether a UTI is present or not?  May need to rely on markers of inflammation such as a CRP or procalcitonin but that is not 100% sensitive or specific either but may be the best we have at the moment to determine how to interpret such situations. Lastly, Slow Down And Practice Good Hand Hygiene So much of what I said above is important when determining if an infection is present or not. The importance of preventing infection cannot be understated. Audits of hand hygiene practice more often than not demonstrate that physicians are a group with some of the lowest rates of compliance. Why is that? As a physician I think it has nothing to do with ignorance about how to properly perform the procedure but rather a tendency to rush from patient to patient in order to get all the things done that one needs to do well on service or call. If we all just slow down a little we may eventually have less need to run from patient to patient as the rate of infections may drop and with it demand for our time.  If slowing down is something that you too think is a good idea you may want to have a look at the book In Praise of Slowness by Carl Honore (TED Talk by Carl Below)  which may offer some guidance how to do something that is more easily said than done. Here is hoping for a little slower pace in the new year. We could reap some fairly large benefits! https://www.ted.com/talks/carl_honore_praises_slowness?language=en    

AllThingsNeonatal

AllThingsNeonatal

 

Dextrose gel for hypoglycemia: Safe in the long run?

The Sugar Babies trial was the subject of a post earlier this year as the largest trial to date examining the effects of using dextrose gel to treat hypoglycemia.  For an analysis of the use of gel in this situation please see the original post Glucose Gel For Neonatal Hypoglycemia: Can We Afford Not To Use It? In summary though, the trial involved 118 infants who received 40% dextrose gel vs 119 who received a placebo gel. All of the infants in this study were selected based on risk factors for hypoglycemia (IDM, IUGR, LBW, LGA, near term) and were all 35 weeks or greater. Each infant had to be less than 48 hours of age when enrolled. Infants received 0.5 mL/kg 40% dextrose gel (200 mg/kg). This was designed to deliver the same amount of sugar as would be given with a D10W bolus of 2 mL/kg. In order to receive the treatment the blood glucose had to be < 2.6 mmol/L so equivalent to our own standards in Canada and the US. Treatment failure, which was the primary outcome was defined as a blood glucose < 2.6 mmol/L despite two treatments with gel.  The studies most important findings were a reduction in NICU admission and greater breastfeeding rates at 2 weeks of age (due to avoidance of formula feeding to keep the glucose stable). But Is It Safe? With any new strategy though, questions arise regarding safety of the product in the long term.  As one reader commented after the original post, could the red dye be harmful in some way or perhaps some other constituent of the gel?  The authors of the original study have now published the follow-up paper entitled Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial.  The findings were a little concerning to me in that there was a high rate of neurosensory impairment in both arms (sham and glucose gel) with the following findings.  None of the differences were significant however. Looking at these results you could be dismayed that the glucose gel did not show any benefit compared to standard therapies for hypoglycemia but if you look at the original study one could equally ask why would we have expected it to? Should The Results Surprise Us? All of the newborns in either arm had an episode of hypoglycemia recorded in order to qualify for entry into the study.  The glucose gel was effective compared to placebo in reducing admissions and increasing breastfeeding rates (which one might think would improve outcomes) but we don't know what the drop off rate in breastfeeding was after 2 weeks. What I can say though is that if there were significant adverse side effects with the glucose gel I would have expected to see some differences in outcome favouring the placebo group which did not occur. An additional issue is we know that the placebo group had more treatment failures meaning they would have had more newborns in the original study with a second low glucose.  Would this favour a worse outcome in the placebo group?  If so does the equivalence in groups suggest that the dextrose gel might worsen outcomes? Unfortunately, what this study is really missing is some indication of how low and how long the blood sugars remained under 2.6 mmol/L in both arms of the study.  We know the mean low glucoses were similar but what about duration and range? While the rates of mild, moderate and severe impairment are the same we don't know how severe the hypoglycemia was which if unbalanced between the groups could actually lead to very different conclusions here.  For example, let's say the glucose gel group had an over representation of infants with 3 or more episodes of hypoglycemia compared to the placebo arm.  The fact that the outcomes are equivalent would suggest that the glucose gel is in fact protective. What Can We Say? I suspect that while glucose gel is effective, to truly assess harm across many different aspects of development we will need larger sample sizes.  We also have to take the results of this study with a grain of salt as so many that have come before it have seen outcomes at school age reveal different findings than when assessed at 2 years of age as in this study. From my standpoint though I will continue to advocate for the use of glucose gel as the reduction in NICU admissions and enhancement of breastfeeding rates especially if sustained are well worth the efforts to implement this strategy if you aren't using it already.

AllThingsNeonatal

AllThingsNeonatal

 

A New Strategy To Prevent Damage in the Preterm Brain

One of my very early posts on this blog pertained to my fascination with an Israeli strategy of monitoring end tidal CO2 in place of drawing blood gases.  Please see A Strategy to Minimize Blood Sampling in ventilated premature and term infants.  The gist of this strategy is that by sampling distal CO2 measurements near the carina you obtain a non diluted sample of CO2 as compared to the traditional proximal end tidal measurement.  The authors have shown this to be highly accurate compared to comparable arterial samples during both conventional and high frequency oscilatory ventilation. This month the same group published a follow-up study that has me excited again about this technological approach.  The paper is entitled Impact of Continuous Capnography in Ventilated Neonates: A Randomized, Multicenter Study.  In this multicentre study 55 infants were ventilated through double lumen endotracheal tubes.  The first group of 25 were randomized to an open group in which the continuous CO2 measurement was available to clinicians to base ventilator management on.  The second group had these values recorded but the treating physicians were blind and based ventilatory changes on arterial blood gas sampling. The primary outcome was based on the percentage of time pCO2 was kept between 30 - 60 with the goal range for permissive hypercapnea being 45 - 55. The Results "Compared with infants in the masked group, those in the monitored group had significantly (P = .03) less time with an unsafe dETCO2 level (high: 3.8% vs 8.8% or low: 3.8% vs 8.9%). The prevalence of intraventricular hemorrhage or periventricular leukomalacia rate was lower in the monitored group (P = .02) and was significantly (P < .05) associated with the independent factors dETCO2 monitoring and gestational age." The same held true for the blood gas values with statistically significant benefits in terms of keeping CO2 within the predefined safe range. My Interpretation The findings make a great deal of sense.  Sampling continuously and adjusting ventilation in real time (assuming a strong correlation between EtCO2 and blood gases) makes sense.  Blood gases done even every four hours can not compare to having results available continuously.  As such I tend to believe the findings of better accuracy.  Although the incidence of IVH and PVL are part of the secondary outcomes there is significant biologic plausability to these findings.  We know that cerebral blood flow is very sensitive to PCO2 with low values causing cerebral vasoconstriction and high values dilation of these same vessels.  Furthermore having wide swings in CO2 could lead to periods of ischemia and then significant reperfusion with resultant injury.  Finding that these two outcomes are increased with intermittent sampling therefore is plausible and deserving of further study. Challenges That Need to Be Addressed Since the publications by the same group showing the accuracy of this method of sampling CO2 we have tried this strategy for several infants.  In short, it works and is very accurate.  We have been able to avoid many blood gases along the way but there remains a significant challenge with avoiding blockage of the second port for sampling.  Furthermore, secretions if getting past the end of the port and into the microstream sampling device can damage the analyzer such that we have only one left functioning in our units. As eager as I am to roll this out as a change in practice we need to address these technical issues but once accomplished this may truly have an impact as a cerebral protective strategy for the preterm infant and with time and further long term outcomes available offer a meaningful way of reducing disability in this population.

AllThingsNeonatal

AllThingsNeonatal

 

An Alternative to Meds For Neonatal Abstinence?

As anyone who has been reading this blog knows, I have an affinity for anything that is non-invasive and improves the care of newborns.  Add to this my interest in Neonatal Abstinence (which has been the focus of other pieces such as Long term cognitive deficits in infants exposed to in-utero opioids and polysubstance use. In a rare finding, girls may have worse outcomes.) and a recent report of laser acupuncture for adjuvant treatment of neonatal abstinence syndrome would have to pique my interest.  In 2014 a case report entitled  Laser acupuncture as an adjuvant therapy for a neonate with neonatal abstinence syndrome (NAS) due to maternal substitution therapy: additional value of acupuncture. was published by Raith.  I recall seeing this paper prior to starting this blog and Facebook page and made a mental note to check it out someday.  That someday is upon me now that an RCT has been published on the subject which will be looked at below. What is laser acupuncture? Before we get into critiquing such a study it is worth explaining what laser acupuncture is.  From the website acupuncture today I found the following background: "In 1991, a study was done in Novosibirsk, Russia that applied directly to the study of acupuncture. Researchers shined light on various parts of the body and found that light traveled under the skin to other acupuncture points, but it didn't travel to places that were not on acupuncture meridians. It appears that the body contains a sort of fiber optic network—where light enters an acupuncture point, travels through the meridian and can be detected at other places along the meridian with a sensitive photon detector. This is a fascinating study showing how light is actually received, used and transmitted throughout the body." The RCT in question above is another paper by Raith W et al Laser Acupuncture for Neonatal Abstinence Syndrome: A Randomized Controlled Trial. This study compared patients receiving treatment for NAS with morphine and phenobarbital and compared 14 in each group on a blinded fashion to laser acupuncture or nothing in addition to the standard regimen.  They avoided the need for a placebo in that the intervention was done by the health care provider and then a separate person calculated a pain score who was blind to whether the laser had been provided or not.  By blinding the people scoring they hoped to address the criticism that would be present had the study been unblinded. The acupuncture was performed daily at five ear and four body points bilaterally with the primary outcome being duration of oral opiate use.   The authors found a reduction in days of opiate treatment but being a small study it would be considered a pilot at best.  The results were 28 days (22 to 33) vs 39 days (32 to 48), respectively, P =.019 and the authors make a comment that phenobarb levels were similar between the groups as well but with overall shorter lengths of stay of 35 days (25 to 47) vs 50 days (36 to 56), respectively, P = .048.  There are several issues with the study though and they are as follows.  Yes, the light therapy was provided behind a closed door but how do we know that the providers truly kept it a secret during the whole stay of the patient? What medications were the mothers taking and at what doses and for what duration?  Was the exposure between groups really the same? Also there was no standard means of weaning that I can see so how do we know by chance that the difference is simply who was on at the time with respect to physician deciding on aggressiveness of weaning.  Another issue is that women on replacement medications such as methadone or suboxone were excluded as were women with polysubstance abuse.  How close to our patient population really were these patients?  Lastly, nearly significant was a preponderance of males in the conventional group and we all know how males generally do compared to females in most studies.  Nonetheless it is a exciting study to imagine an effect from and that is what the authors I think were banking on. What about laser acupuncture for treatment of pain? One other study comparing sucrose to laser acupuncture for prevention of pain with heel lances. In this study of 42 infants randomized to the intervention or sucrose the authors concluded that sucrose was superior to acupuncture for managing pain from heel lancing.  This study did not have a third arm in which no treatment was given (likely due to it being unethical) so what we can't say for sure is whether laser is better than nothing. Personally I find a bit of a leap to believe that shining a light through the skin would have an effect on pain perception by anyone.  I can certainly understand the concept of putting a needle into tissue or applying pressure no different from the effect of rubbing ones temples when they have a headache (works for me at least).  The Chemistry major in me though has trouble with the effect of photons passing through tissue even if directed at acupuncture points.  Having said that the only positive thing I can say is that a quick search for such instruments shows them to be commercially available and as cheap as $50 or so.  I have no doubt there are people who will read this RCT and be impressed with its additional purported impact on NAS and thankfully if they do decide to pursue this intervention they will not have spent a fortune on it.  Money in health care should be directed to what works to help patients and the skeptic in me just isn't buying this even if it appeals to my curiosity with non-invasive strategies.

AllThingsNeonatal

AllThingsNeonatal

 

Time for the "cath urine" to go!

It is one of the first things that a medical student pledges to do; that is to do no harm. We are a fearful lot, wanting to do what is best for our patients while minimizing any pain and suffering along the way. This is an admirable goal and one which I would hope all practitioners would strive to excel at. There are times however when we can inadvertently cause more harm than good when we try to avoid what we perceive is the greater harm.
This is the case when it comes to collecting a sample of urine for culture as part of a full septic workup. If you ask most healthcare providers they will freely acknowledge that the gold standard for determining whether an infant has a UTI is a supra pubic aspirate (SPA). We so rarely do them these days however due to a whole host of reasons. Problems with collection include the timing and accuracy of needle placement both of which may often lead to an empty tap.  Secondly after a number of missed attempts and a crying infant who appears to be in pain it is understandable why bedside nurses may become frustrated with the entire experience and urge the person performing such procedures to settle on a bladder catheterization (BC) to obtain the specimen. The Study That Compares BC and SPA Head to Head A recent Turkish study by Eliacik K et al published A Comparison of Bladder Catheterization and Suprapubic Aspiration Methods for Urine Sample Collection From Infants With a Suspected Urinary Tract Infection and should give us all cause for concern.  The authors performed SPA on 83 infants under 12 months with a positive urine culture by BC but who had not yet started antibiotics.  The outcome of interest was both the comparison with the culture result and to see if urinalysis from the BC could increase the strength of the information gleaned from a BC. All in all the BC performed quite poorly when compared to the gold standard.  The false positive rate compared to SPA was 71.1%! That is to say that only 28.9% of SPA samples were positive compared to BC.  Similarly urinalysis sensitivity and specificity from BC were 66.7% (95% CI, 44.68% to 84.33%) and 93.22% (95% CI, 83.53% to 98.08%), respectively.  This means that only 2/3 of the time was the urinalysis abnormal on a BC in the presence of a true UTI.  Somewhat reassuring is that when there really was no UTI the urinalysis was mostly negative but in almost 1/10 patients it would not by itself rule out a UTI. What Is The Harm in Continuing BC Instead of SPA? When we try to avoid the perceived painful experience of a SPA we are going to wind up treating a large number of patients for a presumed UTI who don't have one.  The harm in this is the exposure of such infants to prolonged courses of antibiotics which has been a subject discussed many times over on this site.  We put our patients at risk of antibiotic resistance and shifts in the gut microbiome which in the case of the preterm infant puts them at risk of necrotizing enterocolitis.  There are many other concerns with prolonging antibiotics but these few should be reason enough to strive for accuracy in obtaining the right specimen in the right way.  Putting it in a slightly different perspective, would you settle for an alternative test to a lumbar puncture which claimed to miss 1 in 10 cases and also found meningitis where there was none 71.1% of the time?! A Way Forward - A Recipe For Success As the saying goes, measure twice and cut once.  With the use of bedside ultrasound there should be no need to guess as to whether the bladder is full or not.  Secondly the placement of the needle should no longer need to rely on landmarking but actually seeing where the best place for needle placement is.  Assessing the bladder by ultrasound is easy and is already employed at the bedside by nurses in many areas of the hospital.  There should no longer be a reason for the empty tap as the practitioner can be called when the baby is ready as evidenced by a good amount of urine in the bladder. Given that we have some time to do the blood culture and LP, while we wait for the SPA to be done either sucrose in the premature infant or IV analgesic may be given for the SPA while in the term or older infant there is an opportunity to put a topical analgesic cream over the site.  There really is little need for pain to factor into this any longer. Ask any health care provider and they will tell you they want to do the best they can for their patient.  This study shows us that performing a BC is failing to meet that goal.  We need to change our ways and return to the practice of the SPA but this time we have to get it right.

AllThingsNeonatal

AllThingsNeonatal

 

Partnering With Parents: One Size Does Not Fit All

Originally posted at: https://winnipegneonatal.wordpress.com/ Facebook Page: https://www.facebook.com/allthingsneonatal/ The journey from conception to the labour floor and then for some to the NICU is not a straight one.  There are times of joy, interspersed with sadness, denial, anger and eventually acceptance, as initial news of being pregnant leads to complications in pregnancy and then eventual admission of an infant to the NICU. Much has been said in recent years about the building of partnerships with parents and in fact there is a new catchphrase attached to the concept "shared decision making" (SDM).  There is no question that in the perfect world this is exactly the relationship that we should be striving for with all of our patients.  The world however is not perfect and although this may not be the most popular opinion I have given, I question how applicable this really is in many situations. A Reality Check Take for instance the parents who present to the labour floor of their local hospital in advanced labour at 24 weeks.  Proponents of this SDM model would suggest that a meeting take place and pertinent information be given to a family and together with the assistance of literature applicable to their situation (possibly a pamphlet) the health care providers and families come to a mutually agreeable decision as to what the best course of action is for them and their unborn infant.  This all sounds wonderful but examining the real life situation a little more closely is it actually reasonable to assume we can obtain this?  I have not been, nor will I ever be pregnant and certainly have never experienced contractions and felt the veil clouding my vision as the first dose of analgesia enters my veins to deal with the discomfort a woman experiences during labour.  Not to mention there are people admitting this couple, taking histories, establishing IV access, scanning bellies and a whole host of other pokes and prods along the way. My Role Better Defined Then I come in.  Among all this chaos I deliver the information, pass along a pamphlet and do the best job I can to inform said couple of the upcoming decision.  The trouble of course is how do we come to this mutual decision in the 15 - 30 minutes I spend with them during this crisis?  The answer sadly is we do our best but don't for a minute think that SDM has occurred.  I don't believe this is possible unless the family has prior experience with a preterm birth or perhaps is a HCP working with newborns or children with disabilities themselves.  In fact Boss RD et al in their own research on the subject identified that in hindsight religion, spirituality and hope are what motivated parents rather than what was said at the time.  In essence their minds are already made up.  It doesn't mean we shouldn't strive for the SDM but at least in my opinion, unless their contractions settle, a calmness ensues, they have time to digest the information being given and then meet again under less stressful circumstances, the SDM is a nice idea but for many not a reality. Shifting To The NICU I recall a significant moment in my training when I saw how the SDM model can actually cause more grief than help.  Dr. Keith Barrington a fellow blogger (if you haven't discovered him, his work is fascinating over at Neonatal Research) published one of the most impactful pieces of research of the decade during my fellowship.  The adverse neuro-developmental effects of postnatal steroids in the preterm infant: a systematic review of RCTs. Following this analysis there was a near moratorium on the use of post natal steroids.  The issue this created was that to now receive them you had to be close to the end of the limits of care.  At this point you either died (thereby concluding they are of no help) or you survived with disability that was due in part no doubt to how sick you had become (thereby concluding they are dangerous). The moment I am referring to was a conversation with a family in which the attending managing the unit presented the risks and benefits of postnatal steroids to the family when the FiO2 was at 40% one day.  The language used was non directive and the parents asked for another day to decide. The next day and each of the following two days they were unable to choose between giving the steroids and the perceived risk of brain damage versus not and watching the FiO2 climb by about 10% per day.  By the time the FiO2 several days later was at 80-90% they were distraught, teary and feeling helpless.  What they needed was direction; someone to give them some advice or more simply an educated opinion. We can strive to share in the decision making but I continue to believe there is a time and place to help our families by taking a stance or side.  We can equip them with as much information as we want but is there really any replacement for actually taking care of these infants, experiencing the ups and downs and hearing how they have done in follow-up? We simply can't expect the average parent to understand the true long term consequences of their decisions.  I am not saying we go back to a paternalistic time in medicine but I am saying that one size does not fit all. We owe it to our families to pursue SDM when we can but we have an equal obligation to recognize when this ideal state is simply not possible.  At this point we have to use the experiences and knowledge we have to provide them with the best advice we can.  We have gone through medical training, and gone down these paths so many times.  We can avoid biased opinion and rely on the facts as they are in our institutions but to not take a stand when it is needed at least for me is doing a disservice to those we are so eager to help.

AllThingsNeonatal

AllThingsNeonatal

 

Apgar score of 0 at 10 minutes: Why the new NRP recommendations missed the mark.

Originally posted at: https://winnipegneonatal.wordpress.com/ Facebook Page: https://www.facebook.com/allthingsneonatal/ As I read through the new NRP recommendations and began posting interesting points on my Facebook Page I came across a section which has left me a little uneasy. With respect to a newborn 36 weeks and above who is born asystolic and by ten minutes of age continues to remain so and has an apgar score of zero the recommendation that has been put forward is this: An Apgar score of 0 at 10 minutes is a strong predictor of mortality and morbidity in late-preterm and term infants.  We suggest that, in babies with an Apgar score of 0 after 10 minutes of resuscitation, if the heart rate remains undetectable, it may be reasonable to stop resuscitation; however, the decision to continue or discontinue resuscitative efforts should be individualized. Variables to be considered may include whether the resuscitation was considered to be optimal, availability of advanced neonatal care, such as therapeutic hypothermia, specific circumstances before delivery (eg, known timing of the insult), and wishes expressed by the family (weak recommendation, very-low-quality evidence). There are some significant problems with this part of the statement. They claim that the apgar score at ten minutes is a strong predictor but when you look at the analysis of the evidence presented in the body of the paper it is weak at best.  I am not clear how one declares the prediction is strong in the face of poor evidence but I will acknowledge intuitively that this makes some sense but do challenge them on the use of the word "strong". 2.  They are correct in acknowledging that the introduction of hypothermia in such settings has changed the landscape in as much as I find it quite difficult to prognosticate unless a child is truly moribund after resuscitation.  Given such uncertainty it is concerning to me that this recommendation may be committed to memory incorrectly in some places that do have access to cooling and may be used more rigidly as though shalt stop at 10 minutes. 3.  In the middle of a resuscitation it is quite difficult to process all of the facts pertaining to a particular newborn while orders for chest compressions, emergency UVCs and epinephrine are being given.  Can we really individualize within ten minutes accurately and take the families wishes truly into account?  This just does not seem practical. 4.  The families wishes are taken into account but inserted as a "weak recommendation".  How can the wishes of the family in any family centred model of care be minimized in such a way even if we believe the situation to be dire? 5.  Since the introduction of hypothermia there appears to be a near 50% survival rate in such newborns and as the authors state 27% of survivors who received cooling had no moderate or severe disability.  Here in lies my greatest issue with this guideline and that is the hypocrisy this position takes when you compare populations at 23 and 24 weeks gestational age.  Survival at these GA in the recent NEJM study of almost 5000 preterm infants under 27 weeks were 33 and 57 % respectively at 23 & 24 weeks with rates of survival without moderate or severe disability being 16 and 31% in the two groups.  The fallout from this and other studies at the extremes of gestational age have been that we should be more aggressive as the outcomes are not as bad as one would predict.  How can we argue this for the 23-24 week infants and for term infant with the same likelihood of outcomes we would unilaterally stop in many centres?! So Now What Do We Do? We are supposed to be practising family centred care and much like the argument at the edge of viability the same should apply here.  The wishes of the family should never be minimized.  Arguably it may be very difficult in such an unexpected scenario to appraise a family of the situation and have clarity around the issue but if a heart rate can be restored after a few more minutes do we not owe it to the family and the child to bring the infant back to the NICU and see what transpires especially if cooling is available? The million dollar question of course is where do we draw the line?  No heart rate at 15, 20 minutes?  Based on the evidence thus far it seems to me that a little longer than 10 minutes is reasonable especially in well equipped centres with access to cooling and modern ventilation and treatments for pulmonary hypertension.  How long though must be individualized and should be determined in partnership with the team caring for the patient which must include the family.

AllThingsNeonatal

AllThingsNeonatal

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