Jump to content

JOIN THE DISCUSSION!

Want to join the discussions?

Sign up for a free membership! 

If you are a member already, log in!

(lost your password? reset it here)

99nicu.org 99nicu.org

HIE and Hypothermia therapy


Guest sjbrott

Recommended Posts

Guest sjbrott

Is anyone trying hypothermia, systemic or cranial, to minimize the effects of HIE? Candidates for this form of therapy must first be placed on aEEG to determine if any brain activity is present. Sustained cranial or systemic hypothermia needs to be initiated by 6 hours from birth to be effective.

Link to comment
Share on other sites

Is anyone trying hypothermia, systemic or cranial, to minimize the effects of HIE? Candidates for this form of therapy must first be placed on aEEG to determine if any brain activity is present. Sustained cranial or systemic hypothermia needs to be initiated by 6 hours from birth to be effective.

Hypothermia is a hot issue ;) - we participated in the UK-based TOBY-trial and now "post-TOBY" the Swedish Neonatal Society is discussing if/how/when hypothermia should be considered a treatment option. I saw the draft of clinical guidelines just the other day, will report when it is official!

Link to comment
Share on other sites

Hypothermia may be the only hope for asphyxiated infants. The evidence from 2 large RCTs supports the use of selective head cooling and total body hypothermia, However the evidence is not that clear and it is premature to recommend brain cooling until results of more trials like the TOBY trial are published and a metanalysis completed.

1- CooLCAP trial ( Gluckman PD, Wyatt JS, Azzopardi D, et al. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy:

multicentre randomised trial. Lancet 2005;365:663-70).

234 term infants with moderate to severe neonatal encephalopathy and abnormal amplitude integrated electroencephalography (aEEG) were randomly assigned to either head cooling for 72 h, within 6 h of birth, with rectal temperature maintained at 34–35°C (n=116), or conventional care (n=118). Primary outcome was death or severe disability at 18 months. Analysis was by intention to treat. We examined in two predefined subgroup analyses the effect of hypothermia in babies with the most severe aEEG changes before randomisation—ie, severe loss of background amplitude, and seizures—and those with less severe changes.

Findings In 16 babies, follow-up data were not available. Thus in 218 infants (93%), 73/110 (66%) allocated conventional care and 59/108 (55%) assigned head cooling died or had severe disability at 18 months (odds ratio

0·61; 95% CI 0·34–1·09, p=0·1). After adjustment for the severity of aEEG changes with a logistic regression model, the odds ratio for hypothermia treatment was 0·57 (0·32–1·01, p=0·05). No difference was noted in the

frequency of clinically important complications. Predefined subgroup analysis suggested that head cooling had no effect in infants with the most severe aEEG changes (n=46, 1·8; 0·49–6·4, p=0·51), but was beneficial in infants

with less severe aEEG changes (n= 172, 0·42; 0·22–0·80, p=0·009).

Interpretation These data suggest that although induced head cooling is not protective in a mixed population of infants with neonatal encephalopathy, it could safely improve survival without severe neurodevelopmental disability in infants with less severe aEEG changes.

2- NICDH Whole Body Hypothermia Trail (Shankaran S, Laptook AR, Ehrenkranz RA, et al. Whole-body hypothermia for neonates with hypoxic–ischemic encephalopathy.N Engl J Med 2005;353:1574-84.

Of 239 eligible infants, 102 were assigned to the hypothermia group and 106 to the control group. Adverse events were similar in the two groups during the 72 hours of cooling. Primary outcome data were available for 205 infants. Death or moderate or severe disability occurred in 45 of 102 infants (44 percent) in the hypothermia group and 64 of 103 infants (62 percent) in the control group (risk ratio, 0.72; 95 percent confidence interval, 0.54 to 0.95; P=0.01). Twenty-four infants (24 percent) in the hypothermia

group and 38 (37 percent) in the control group died (risk ratio, 0.68; 95 percent confidence interval, 0.44 to 1.05; P=0.08). There was no increase in major disability among survivors; the rate of cerebral palsy was 15 of 77 (19 percent) in the hypothermia group as compared with 19 of 64 (30 percent) in the control group (risk ratio, 0.68; 95 percent confidence interval, 0.38 to 1.22; P=0.20). Conclusions Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic–ischemic encephalopathy.

In developing countries economic methods for cooling like ice bags, electric fan may be used, however, the problem will be the availability of aEEG machines which are expensive, yet, very crucial for the selection of infants in hypothermia trials.

We had difficulty in enrolling infants in multicenter trials because of that.

Any suggestions for some research group that can provide us with aEEG and we can paricipate in a RCT that looks at economic methods of head cooling that can be applied in developing countires (where the problem of asphyxia is more common and number of babies who can benifit is larger)

Link to comment
Share on other sites

  • 3 months later...
Guest sjbrott

Earlier this year the US Federal Drug Admin (FDA) recentently approved the Olympic Neonatal Cool Cap. The effectiveness will be followed through the Vermont Oxford Network.

Note: Total body cooling including the Cool Cap has been having better results to date.

Link to comment
Share on other sites

Guest cihanber

thanks a lot sjbrott ,

is there any web adress or source to look at this things and to buy coolcap or blanket ?

Link to comment
Share on other sites

Guest j.micallef
Hypothermia is a hot issue ;) - we participated in the UK-based TOBY-trial and now "post-TOBY" the Swedish Neonatal Society is discussing if/how/when hypothermia should be considered a treatment option. I saw the draft of clinical guidelines just the other day, will report when it is official!

Hi Stefan

I was wondering wether you are treating asphyxiated infants with hypothermia outside of a controlled trial?

Have the Swedish "post-TOBY" guidelines been published yet?

best regards

John

Link to comment
Share on other sites

Hi Stefan

I was wondering wether you are treating asphyxiated infants with hypothermia outside of a controlled trial?

The answer is yes, there are now guidelines for cooling, but all treated infants are included in an observational study. I don't have the guidelines at hand right now, but pathol CFM is NOT included as a criteria.

Personally I feel more research is needed on this technique and thaht CFM seems to be a reasonable inclusion criteria. But I can also understand that one may argue that the treatment works, although I think the scientific evidence is a bit weak so far.

Link to comment
Share on other sites

  • 2 weeks later...

Dear all

In sweden we have as mentioned by Stefan Johansson been running Cooling studies with Toby guidlines as a base for the new Swedish Guidlines.

We are now in most places recruting children that is forfilling the old criterias of Toby but with the extention that CFM is not a must but a should if you have a CFM at the clinic. The Arguments for not having it as a mandatory at the inclusion are a few. Here is one of them : In sweden we wanted to be able to start as soon as possible with the cooling. And if you have a transport "issue" (from a local hospital to the speciallity clinic) and you are monitoring the childs temperature and other important vital parameters, you the can start cooling the child during transport and then at the speciallity clinic exclude the child if the CFM shows othervise. We will then not have a child that miss the 6 Hour start of cooling limit due to rules. Though I belief all clinics in sweden will try to monitor with a CFM if possible already from start since this is common sense.

Link to comment
Share on other sites

Swedish cooling.

In sweden we are using at nearly all places the Tecotherm 200 whole body cooling system, we have not closed our boarders to other inventions or ideas but since the Tecotherm was used in TOBY we have kept using it. Olympics Cool cap has been considered in at a few sites but the price and the support have not been what we have wanted so far. ( But I am hopeful that this text will put these issues to a thing from the past or a historic event will happen when both the olympic and the Tec compamy in germany will say now we will give great support.) There have also been arguments that the mother/father comes closer to the child and is not so frightend by the equipment as if the child has a cap with cooling fluid running throw it.

We are now developing and doing research in sweden for a safe new method that will be able to use in the transport situation, in remote locations or in the local hospital in the time before a transport to the speciallity cliic, and hopefully all over the world. Since this is a research project we will have to get the results before clinical trials can start but the results are really promissing.

Link to comment
Share on other sites

  • 10 months later...
Guest rajunarasimhan

Hi there,

Here in the UK, many neonatal units are providing hypothermia therapy as per the TOBY guidelines but without the need for aEEG criteria. These babies are then entered into the TOBY register for followup purposes.

Link to comment
Share on other sites

  • 1 year later...
Guest Liliroom

Hello,I am a Neonatal Nurse ,we had recently a baby with severe asphyxia and we were using a simple non professional technique for head cooling.

I would like to know what are the appropriate techniques for head cooling and what are the equipment needed in this case.

Thank you advance,

Liliroom

Link to comment
Share on other sites

I do not know of simple techniques for selective head cooling but the Australian trial ICE used a pragmatic approach to induce systemic cooling with ice packs.

I have heard about this method at the Hot Topics congress, but have found only one reference in Medline, from 2004. It might be so that they have not reported more from this trial. The researchers' bottom-line was... there are lots of fancy equipment but ice-packs serve the purpose almost as good.

Inder T, Hunt R, Morley C, Coleman L, Stewart M, Doyle L, Jacobs S. Randomized trial of systemic hypothermia selectively protects the cortex on MRI in term hypoxic-ischemic encephalopathy. Journal of Pediatrics 2004;145:835-7

http://www.ncbi.nlm.nih.gov/pubmed/15580212

I suggest you contact the authors of this report for advice.

Link to comment
Share on other sites

A prelimenary report just published this year:

Horn A, Thompson C, Woods D, Nel A, Bekker A, Rhoda N, Pieper C. Induced hypothermia for infants with hypoxic- ischemic encephalopathy using a servo-controlled fan: an exploratory pilot study.

Pediatrics. 2009 Jun;123(6):e1090-8. Epub 2009 May 11.

Division of Neonatal Medicine, School of Child and Adolescent Health, University

of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.

alan.horn@uct.ac.za

OBJECTIVE: Several trials suggest that hypothermia is beneficial in selected

infants with hypoxic-ischemic encephalopathy. However, the cooling methods used

required repeated interventions and were either expensive or reported significant

temperature variation. The objective of this pilot study was to describe the use,

efficacy, and physiologic impact of an inexpensive servo-controlled cooling fan

blowing room-temperature air. PATIENTS AND METHODS: A servo-controlled fan was

manufactured and used to cool 10 infants with hypoxic-ischemic encephalopathy to

a rectal temperature of 33 degrees C to 34 degrees C. The infants were sedated

with phenobarbital, but clonidine was administered to some infants if shivering

or discomfort occurred. A servo-controlled radiant warmer was used simultaneously

with the fan to prevent overcooling. The settings used on the fan and radiant

warmer differed slightly between some infants as the technique evolved. RESULTS:

A rectal temperature of 34 degrees C was achieved in a median time of 58 minutes.

Overcooling did not occur, and the mean temperature during cooling was 33.6

degrees C +/- 0.2 degrees C. Inspired oxygen requirements increased in 6 infants,

and 5 infants required inotropic support during cooling, but this was

progressively reduced after 1 to 2 days. Dehydration did not occur. Five infants

shivered when faster fan speeds were used, but 4 of the 5 infants had

hypomagnesemia. Shivering was controlled with clonidine in 4 infants, but 1

infant required morphine. CONCLUSIONS: Servo-controlled fan cooling with

room-temperature air, combined with servo-controlled radiant warming, was an

effective, simple, and safe method of inducing and maintaining rectal

temperatures of 33 degrees C to 34 degrees C in sedated infants with

hypoxic-ischemic encephalopathy. After induction of hypothermia, a low fan speed

facilitated accurate temperature control, and warmer-controlled rewarming at 0.2

degrees C increments every 30 minutes resulted in more appropriate rewarming than

when 0.5 degrees C increments every hour were used.

Link to comment
Share on other sites

Horn A, Thompson C, Woods D, Nel A, Bekker A, Rhoda N, Pieper C. Induced hypothermia for infants with hypoxic- ischemic encephalopathy using a servo-controlled fan: an exploratory pilot study.

Pediatrics. 2009 Jun;123(6):e1090-8. Epub 2009 May 11.

But I wonder if this is really the same technology as used in the ICE trial?

I have a slight memory from a meeting and it seemed that the "ice pack"-strategy had no servo-control, but seemed very basic. BUT, it worked.

Anyone from Australia/New Zealand who could comment on this?

Link to comment
Share on other sites

  • 2 years later...
Guest Nicunurseinnb

We use the Olympic cool cap system...

http://www.hospimedicaintl.com/index.php?cPath=8_140&crdID=2b320db3dc13bfd93f89fdd77969a116

We use it on average a couple of times a year. It's actually in use right now in our unit. The last time it was used the baby did not survive...the HIE was too severe and he had no response at all. We kept the treatment going for the 72 hours and did the rewarming then made the decision to remove care (or course, after the dr spoke with parents...). The one previous to that one had a great outcome. Went home two days post treatment.

It does save lives....

Link to comment
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now
×
×
  • Create New...