Neonatal Hypothermia

A Method to Provide Neuroprotection After Hypoxic Ischemic Encephalopathy

Katherine M. Newnam, MS, RN, CPNP, NNP-BC; Donna L. DeLoach, MS, RN, CPNP, NNP-BC


NAINR. 2011;11(3):113-124. 

In This Article

Clinical Trials

Multiple clinical trials have now been completed and replicated to provide protocols for neonatal hypothermia therapy (see Table 3). Research findings provide direction for proposed adjunct therapies to accompany hypothermia with the goal to improve outcomes and/or refine recommendations for both inclusion criteria and long-term outcome predictions. To elucidate the science to date, a brief review of the three seminal research studies will be completed as well as highlights from several integrated reviews on the topic including a Cochrane meta-analysis.

In early 2005, the findings of the Cool Cap multicentered, randomized controlled trial were published.[27] The purpose of the study was "to investigate whether 72 hours of selective head cooling with mild systemic hypothermia started within 6 hours of birth improves neurodevelopment outcome at 18 months in infants with moderate or severe neonatal encephalopathy."[27] Inclusion criteria used a modified Sarnat scoring[28] (see Table 2) as well as aEEG measures to classify the severity of hypoxic injury.

Results of this study demonstrated that half of the cooled infants had unfavorable primary outcome compared with approximately two thirds of the infants who did not receive the cooling treatment. This evidence suggested that selective head cooling had minimal impact on those infants severely affected with significant aEEG changes and/or clinical seizures but was beneficial in infants classified as moderate HIE demonstrated by less severe aEEG changes (refer to Table 1).

Also published in 2005 were the findings of the National Institute of Child Health and Human Development (NICHD) Neonatal Research body cooling trial.[14] Using total body cooling within 6 hours from delivery, the sample included 208 term infants, 102 who received the treatment protocol. There was a significant improvement in the death and severe disability noted when the control (normothermic) group was compared with the treatment (hypothermic) group demonstrated during this randomized controlled trial.[14]

Finally, a third study, described as a pilot study that used total body cooling, was published by Eicher et al.[26,31] This study was large enough to show significant improvement between those infants who were cooled when compared with infants who did not receive the hypothermia treatment.

These seminal clinical trials (see Table 1) have now been replicated with clear scientific evidence to recommend standardized treatment protocols for hypothermia treatment of the neonate. Inclusion criteria, method of cooling as well as target temperatures, and method and timing of warming have now been established and adopted as the standard treatment of HIE (see Table 3). We have come a long way from initial methods of cooling infants by placing gloves filled with cold water around the infant.


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