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  1. Hydrocortisone after birth may benefit the smallest preemies the most!

    This must be one of my favourite topics as I have been following the story of early hydrocortisone to reduce BPD for quite some time. It becomes even more enticing when I have met the authors of the studies previously  and can see how passionate they are about the possibilities. The PREMILOC study was covered on my site twice now, with the first post being A Shocking Change in Position. Postnatal steroids for ALL microprems? and the second reviewing the 22 month outcome afterwards /2017/05/07/early-hydrocortisone-short-term-gain-without-long-term-pain/.

    The intervention here was that within 24 hours of birth babies born between 24-27 weeks gestational age were randomized to receive placebo or hydrocortisone 1 mg/kg/d divided q12h for one week followed by 0.5 mg/kg/d for three days. The primary outcome was rate of survival without BPD at 36 weeks PMA. The finding was a positive one with a 9% reduction in this outcome with the use of this strategy. Following these results were the two year follow-up which reported no evidence of harm but the planned analysis by gestational age groupings of 24-25 and 26-27 weeks was not reported at that time but it has just been released this month.

    Is there a benefit?

    Of the original cohort the authors are to be commended here as they were able to follow-up 93% of all infants studied at a mean age of 22 months. The methods of assessing their neurological status have been discussed previously but essentially comprised standardized questionnaires for parents, assessment tools and physical examinations.

    Let’s start off with what they didn’t find. There was no difference between those who received placebo vs hydrocortisone in the 26-27 week group but where it perhaps matters most there was. The infants born at 24-25 weeks are certainly some of our highest risk infants in the NICU. It is in this group that the use of hydrocortisone translated into a statistically significant reduction in the rate of neurodevelopmental impairment. The Global Neurological Assessement scores demonstrated a significant improvement in the hydrocortisone group with a p value of 0.02. Specifically moderate to severe disability was noted in 18% compared to 2% in the group receiving hydrocortisone.They did not find a difference in the neurological exam but that may reflect the lack of physical abnormalities with cognitive deficit remaining.  It could also be explained perhaps by the physical examination not being sensitive enough to capture subtle differences.

     

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    Why might this be?

    Adding an anti-inflammatory agent into the early phase of a preemies life might spare the brain from white matter damage. Inflammation is well known to inflict injury upon the developing brain and other organs (think BPD, ROP) so dampening these factors in the first ten days of life could bring about such results via a mechanism such as that. When you look at the original findings of the study though, a couple other factors also pop up that likely contribute to these findings as well. Infants in the hydrocortisone group had a statistical reduction in the rate of BPD and PDA ligations. Both of these outcomes have been independently linked to adverse neurodevelopmental outcome so it stands to reason that reducing each of these outcomes in the most vulnerable infants could have a benefit.

    In fact when you add everything up, is there much reason not to try this approach? Ten days of hydrocortisone has now been shown to reduce BPD, decrease PDA ligations and importantly in the most vulnerable of our infants improve their developmental outcome. I think with this information at our fingertips it becomes increasingly difficult to ignore this approach. Do I think this will become adopted widely? I suspect there will be those who take the Cochrane approach to this and will ask for more well designed RCTs to be done in order to replicate these results or at least confirm a direction of effect which can then be studied as part of a systematic review. There will be those early adopters though who may well take this on. It will be interesting to see as these centres in turn report their before and after comparisons in the literature what the real world impact of this approach might be.

    Stay tuned as I am sure this is not the last we will hear on this topic!

  2. As 2017 comes to an end, I'd like to post an update on the probiotics project.

    You may have read previous blog posts about Neobiomics (here and here), a not-for-profit project that will provide probiotics specifically manufactured for preterm infants, “from the community, to the community”. Launch is planned for Q1 2019.

    The probiotics will fulfill specific needs:

    • three bacterial strains documented in a large clinical trial (i.e. the ProPrems trial)
    • manufactured according to GMP, fulfilling the highest possible quality grade (21 CFR Part 106, “Infant Formula grade”)
    • freeze-dried bacterias with superior stability and long shelf-life
    • single dose units (aluminium foil stickpack) to virtually eradicate the risk of contamination

    If you would be interested to use this probiotics product in your NICU, visit this page and submit the form to ensure yourself to learn when this product will become available.

    That's all for now about this exciting project :) 

     

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  3. The APTS (Australian placental transfusion study) trial has just appeared on line. This was a high-quality multicenter, international RCT of immediate cord clamping (less than 10 seconds) compared to delayed clamping (60 seconds) for babies born less than 32 weeks gestation. (Tarnow-Mordi W, et al. Delayed versus Immediate Cord Clamping in Preterm Infants. the FPNEJM 2017.)

    Another trial arriving almost simultaneously is a smaller trial from the UK, which compared cord clamping at less than 20 seconds to clamping at at least 2 minutes, with reuscitation staring with the cord intact in the intervention group. (Duley L, et al. Randomised trial of cord clamping and initial stabilisation at very preterm birth. Archives of disease in childhood Fetal and neonatal edition. 2017.) I will come back to that trial in part 2.

    The benefits of delayed cord clamping for term babies are quite obvious from the RCTs, and basically show a significantly improved Hemoglobin/Iron status for the first year of life, which seems to lead to some improvement in fine motor function, in the long term, with no important down-side. The higher bilirubin levels among late-clamped babies do not lead to more phototherapy, if modern restrictive phototherapy guideline are followed.

    The only real disadvantage is that it is much harder to give blood to a public cord blood bank after delayed clamping. Public banks have been the source of stem cells for bone marrow transplants for hundreds of children (and as far as I know adults as well) so this should not be dismissed...

    For the preterm baby I thought that much of the evidence had been over-hyped, with claims of reduced IVH, and reduced NEC, based on tiny numbers from tiny trials, with no robust evidence of benefit, apart from higher hemoglobins, probably leading to fewer transfusions. What we really needed was a large RCT with enough power to answer questions about  efficacy and safety.

    The APTS trial gives that power, with over 1500 babies randomized, and, although much smaller, the trial from England is the second largest trial, with over 260 babies. The remaining trials that have been quoted as the justification for the worldwide movement for delayed clamping in the preterm, have mostly been tiny, with sample sizes between 32 and 200.

    What did the APTS trial show? Speaking in the strictest sense it showed no difference between groups in the primary outcome. The primary outcome was a composite outcome of death, serious brain injury, late-onset sepsis, necrotising enterocolitis or severe retinopathy. When the study was planned bronchopulmonary dysplasia was also part of the primary outcome, but with changes in practice the authors found that the incidence of "BPD" was much higher than expected (many babies were on respiratory support with positive pressure and 21% oxygen at 36 weeks post-menstrual age), so during the trial, before the final data were analysed, BPD was deleted from the composite outcome. When you look at the individual components of the composite outcome, there is no sign of a benefit for any of the components of that composite, except one, that is mortality.

    nejmoa1711281_t3.jpeg?w=640

    When only one part of a composite outcome is positive, but it is much less frequent than the remaining parts, the overall composite may well be negative. This is one of the problems with composite outcomes, you can actually lose power for the most important part of the composite, whereas these composites are usually being used to try to increase power!

    The outcome of death should therefore strictly be considered to be a secondary outcome, and therefore treated with some scepticism. I'll come back to this point.

    Also important is the fact that 26% of the delayed clamping group did not get 60 seconds of delay, which was most often due to concerns about the neonatal status (70% of the time). This was unavoidable given the design, as most centers were not resuscitating babies with the cord intact. 20% of the delayed clamping group got the cord clamped before 30 seconds, the other 6% who did not follow protocol it was between 30 and 60 seconds.

    It would be interesting to have a "per-protocol" analysis of mortality results, which I would guess would show a greater difference between groups, as babies who had the delayed clamping interrupted because of concerns about neonatal status might well have a higher mortality. There is an analysis of the per-protocol effects on the primary outcome (in the supplementary appendix) which shows a difference (which may just be due to chance, p=0.2) : 37% with immediate clamping, and 33% with delayed clamping, but no mention of the components of that outcome.

    There is also a report of the causes of death in the supplementary appendix, causes which cover the entire range of causes of death among very preterm babies. The biggest single cause was septicemia, which was also the cause that showed the biggest difference between groups, 2.2% immediate clamping, and 0.5% delayed clamping.

    There is also an analysis in detail of head ultrasound findings which show no tendency to be different in any aspect between groups.

    Finally there were many fewer babies who needed blood transfusions with the delayed clamping (61% with immediate clamping, 52% with delayed clamping) but more babies with polycythemia (2% had hematocrit >65% with immediate clamping, 6% with delayed clamping, 1% over 70% immediate, 2% with delayed). There was no clinically important difference in bilirubin concentrations (mean was 3 micromoles higher with delayed).

    Overall then, a potential decrease in mortality, a decrease in the number of babies receiving transfusion, with a very small increase in polycythemia, which was probably not due to chance (p<0.001).

    What to do with these results? Well, as yet there is no signal for a clinically important harm of delayed cord clamping; with the proviso that babies who are intended to have delayed cord clamping may often have the cord clamped early. I think that a clinical approach planning for delayed clamping at, or perhaps after 60 seconds, is consistent with the best evidence, it will decrease the number of babies receiving transfusions, and might decrease mortality.

    We also need an updated systematic review and meta-analysis. But for that you will have to wait for part 3!

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    htawakol
    Latest Entry

    3rd International Neonatal Multispecialty Conferecne

    Abu Dhabi 16th-18th November 2017

    http://www.abudhabinms.com/

    3rd Abu Dhabi Neonatal Conference .pdf

    3rd Abu Dhabi Neonatal Conference .pdf

  4. Presenting the 2nd Presentation of Neonatal CME @ Jamnagar on 25th October. Its : " NEONATAL JAUNDICE- Current Concepts by Dr.Maulik Shah MD. Video link on You Tube: https://www.youtube.com/watch?v=hLMP4FHOdIk. Comments and feedback most welcome.Neonatal_jaundice_maulik.thumb.png.54d6d

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    What is the diagnosis?

    35 gestation weeks, IUGR, preterm gemini B babygirl has dyspnoe and multiplex fibroma around both ears. She is fed via nasogastric tube, because she can not swallow. She has peripapillary pigment ring, hepato-splenomegaly with abnormal ribs, vertebrae and spine morphology (X-ray attached). Other findings were normal. Her brother is well, he only has hydronephrosis on one side without any symptoms.

    Any suggestions are welcome.

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    hi

    Is adrenalin better than dopamine for maintaining/elevating BP in PPHN. Please tell me about your practice

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    Preterm baby 35 week was admitted to NICU for total 5 days

    All investigations were normal including blood C/S , CRP CBC And serum Electrolytes

    In day 4 , Baby develop this rash only for 20 minutes then disappear without treatment

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    What are the indicators we can use to check the quality of care in a neonatal unit?

  5. Mortality rates of congenital heart disease has fallen dramatically over the years, nicely demonstrated by a cohort British study. The annual numbers of deaths decreased from 1460 in 1959 to 154 in 2009. Survival was especially improved in infancy. Infants comprised 63% of all CHD deaths during 1959-63, but only to 22% in 2004-08.

    Naturally, the development of pediatric cardiology, thoracic surgery and pediatric intensive care have been essential for this dramatic improvement.

    The improved situation for infants with congenital heart disease is quite similar and parallel to improved outcomes for preterm infants. Only a few decades ago, the majority of today's survivors would have had a poor prognosis.

    With this growing generation of "new survivors" comes new challenges. In neonatal and adult medicine we know little about aging individuals born preterm, and I believe the same applies to aging individuals born with congenital heart disease.

    Knowles RL, Bull C, Wren C, & Dezateux C (2012). Mortality with congenital heart defects in England and Wales, 1959-2009: exploring technological change through period and birth cohort analysis. Archives of disease in childhood, 97 (10), 861-5 PMID: 22753769

  6. Blog ali

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    ali
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    Hi everyone,

    Blindingly obvious I know, but our visitor numbers seem to have recently exploded. Today we topped 150 at one point. I know membership is increasing but visitor numbers seem to have changed up a gear as well, very exciting. Are we recording visitor numbers? It wouldn't be neonates without a number :)

    Best wishes

    Alistair

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    It sounds simple, but actually it turns out to be very complicated and controversial.

    The question is are we improving our NICU ? Has our NICU performance remained the same for the past few years?

    What about the performance of our NICU staff members (Medical and Nursing ) ? Are they improving themselves?

    That was the easy part.

    Now the difficult part.

    We can only improve a thing which can be measured. So to improve our NICU, we have to monitor some parameters of our NICU and then trend it and then find what we want to improve in that measure and then plan an intervention and then implement that intervention and then monitor the performance after the implementation of the interventions. (phew that was difficult to type right !)

    So lets see....if we heard that NICU in XYZ hospital had mortality of ELBW babies 5 years back of 50 % and that now they are reporting ELBW mortality of 20%...we definitely know they have improved themselves. How about nosocomial infection rate in a NICU in XYZ hospital was 5 per 1000 patient-days 5 years back and now was 1.5 per 1000 patient-days...we definitely know they have improved.

    One very nice example to illustrate this improvement is here: http://www.lafayettegeneral.com/pavilion/Level-III-Neonatal-Intensive-Care-Unit-1/Key-Performance-Indicators-3

    There are so many parameters to be monitored in a NICU..I think we just have to select what is suitable in our setup balancing our resources. We have to be cautious not to overdo it...as then it will only be on paper and have no actual benefit for the NICU.

    the other (more difficult part) is to monitor the performance of NICU staff. Here also there are many options. One beloved one is compliance with infection control practices (especially ...hand hygiene). Success rate of intubations could be used for residents. How about IV infiltration (IV burns) rate for nurses? Morbidity/Mortality outcomes for consultants/attending ?

    Once staff know that they are being monitored...performance automatically improves. Once you start rewarding good performance......then people start having a healthy competition to improve themselves....the ultimate winner is the patient...NICU performance measures improve.....And thats the ultimate aim...to improve patient outcomes...

    The floor is open.

  7. selvanr4
    Latest Entry

    hello to everyone,

    we are leaving Stockholm today after a wonderful educative and progressive conference of evidence based neonatology.

    We had nice interactive sessions lectured by topclass professionals. Had a nice boat trip coupled with a nice welcome function.

    Got into touch with new friends. Personally had direct interaction with the team members who have been known to us only through cyberspace.

    Nice experience and we like to thank everyone.

    see you next time with more to learn.

    bye now

    selvan

    Lotus Hospital

    Erode, Indai

  8. hi every one happy new year where is the image library

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    Dear colleagues....

    Our neonat medicine started in my town Gaza in the 70's, thanks to my professor DR. salwa Aman who alone started the work that time,,,it is was a sort of primitive stuff, she started to collect donations from here and there to build ,buy incubators and other equipment....things went further but slowly on....many of our staff got the training and experience from neighbouring countriers..so we progressed further...forgot to say that i joined dr salwa inطher syruggle to build a neonatal service in early 80's....finally here we are with well-built NICU: 30 incubators, 18 are intensive care, 15 ventilators not so advanced but ok...a staff of 16 physicians, 34 nurse serving 1000 deliveries a month in our hospital,Shifa Hospital..so what do think of our professional journey?..write t o me much like to hear from you...

  9. as a traveler, you meet all kinds of people, experience all kinds of locations, learn different ways of handling the same issue, as well as being in a position to teach and share. while i have been traveling now for 3 yrs, never have i had the last part of this brought home to me as strongly as my currently ending contract, especially the teaching part.

    as a general rule, i don't mind teaching. i enjoy sharing my knowledge and experience, as long as i have time to do it. however, in the middle of coding a baby is not when i prefer to have to be giving instructions to less experienced nurses about removing drapes to maintain warmth, chosing iv sites, how fast to push amp or how to dilute gent (or reminding peds who don't frequently work with neonates about nrp guidelines for bagging...).

    i have missed the level III NICU (this being a low level II Nursery). i have missed being surrounded by peers who know how to hold a baby for iv starts and how to help tape the iv once it's in place. or who know how to mix antibiotics and administer them. or even someone who knows appropriate technique for a heelstick. the little things. and i've missed "sick" babies.

    yes, it's been an invaluable experience. i have revisited skills that i have not had an opportunity to practice as frequently being in larger units where everybody is wanting the experience. i have gained an appreciation for the new grads and their openness for learning, as well as being thankful the more experienced nurses who know when to worry and when not to about a healthy term kid.

    and i have been given the gift of thanks. from parents. from other nurses, both new and seasoned. from techs. and from the peds.

    i have been reminded of my own start in working in this specialty, often laughing at seeing myself in the new grads, and becoming disgusted with myself when i recognize some of the harsher behavior i exhibit towards ignorance that was once visited upon me by those with more experience.

    so, as another contract winds down, i stop to think, and reflect. at the people i have worked with. a few particular cases. the geographical area i'll be leaving. but mostly that i am heading back to a level III NICU where my heart is.

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    First time blogger!! I am finally gaining real clarity now about how I want to be a 'nurse' alongside parents and other caregivers who have babies in the neonatal unit. The concept family centred care needs to be fully integrated into my being. So how do I achieve this? I see colleagues genuinely trying to 'help' families by their nursing actions and yet it continues to frustrate me that some of these actions take away the parents choices and impacts on their ability to fully engage with their neonate. I thought empowerment was the key but that still implies I have the power to give away to the families. Whether I like it or not this may be true purely because of the nature of the NICU environment but it fails to truly show how I work alongside or with the families. I am now convinced that if I can integrate an enabling focus into how I want to be as a nurse I can then be a partner in the care. Any thoughts from colleagues??

    Marpsie

  10. Medhaw

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  11. shesu

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