06 Jul Effect of Depth and Duration of Cooling on Death or Disability at Age 18 Months Among Neonates With Hypoxic-Ischemic Encephalopathy
MedicalResearch.com Interview with:
Dr. Shankaran
Seetha Shankaran, M.D.
Professor, Neonatology
Wayne State University School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The study was performed because infants with moderate or severe hypoxic-ischemic encephalopathy (abnormal neurological exam within 6 hours of birth due to lack of blood and oxygen supply to the brain at birth) have rates of death or survival with disability that were still high in spite of current intensive care including hypothermia.
Whole-body hypothermia, cooling the infant for 72 hours at a depth of 33.5°C that was performed by the Neonatal Research Network funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development was the first trial of this therapy in the USA. We found that hypothermia therapy did decrease the rate of death or survival with disability from 62 to 44%. Since 44% is still high we wanted to see if longer cooling or deeper cooling or both would reduce this rate.
This was a randomized controlled clinical trial to examine whether longer cooling or deeper cooling or both reduced the rate of death or survival with disability among full term neonates with hypoxic-ischemic encephalopathy. The study lasted from October of 2010 to January 2016. 364 infants were enrolled. Neonates were randomly assigned to 4 groups of cooling therapy and the major findings were that neither longer cooling nor deeper cooling nor both were more superior to cooling for 72 hours at 33.5°C.
Our results were surprising because at the time we planned this study there were reports from animal model studies that longer/deeper cooling were more protective to the brain.
MedicalResearch.com: What should readers take away from your report?
Response: In this trial we saw that the rate of death or disability was 29.3% with cooling for 72 hours at 33.5C. This is even lower than the 44% rate we achieved with cooling for 72 hours at 33.5C with our first trial published in NEJM in 2005. The reason for this reduced rate could be that the number of infants with severe encephalopathy was lower in this trial than our first trial, but other changes in care practices may also have helped to reduce this rate.
The take-home message is that the current practice of cooling neonates with moderate or severe encephalopathy should continue to be at 33.5°C for 72 hours
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Investigators are now planning to examine adding additional therapies to hypothermia therapy. They need to be enroll larger numbers of study participants since the rate of death or survival with disability is 29% as shown in this trial.
MedicalResearch.com: Is there anything else you would like to add?
Response: Research funding should continue to support this vital research. Randomized controlled trials like the one we have performed require enrollment of large numbers of infants from multiple centers as the frequency in any one hospital/center is low. The reduction in the rate of death or disability is crucial; currently it is 29% as we noted in our study. Researchers need to work to reduce this rate even further. We need to reduce the rate of cerebral palsy which has lifetime costs to families and society.
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Last Updated on July 6, 2017 by Marie Benz MD FAAD