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Background: Cerebral hypothermia can improve outcome of experimental perinatal hypoxia-ischaemia. We did a multicentre randomised controlled trial to find ou t if delayed head cooling can improve neurodevelopmental outcome in babies with neonatal encephalopathy.Methods: 234 term infants with moderate to severe neonat al encephalopathy and abnormal amplitude integrated electroencephalography (aEEG ) were randomly assigned to either head cooling for 72 h, within 6 h of birth, w ith 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 effec t of hypothermia in babies with the most severe aEEG changes before randomisatio n -ie, severe loss of background amplitude, and seizures-and those with less s evere 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 chan ges with a logistic regression model, the odds ratio for hypothermia treatment w as 0.57 (0.32-1.01, p=0.05). No difference was noted in the frequency of clinic ally important complications. Predefined subgroup analysis suggested that head c ooling 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 althou gh induced head cooling is not protective in a mixed population of infants with neonatal encephalopathy, it could safely improve survival without severe neurode velopmental disability in infants with less severe aEEG changes.
Background: Cerebral hypothermia can improve outcome of experimental perinatal hypoxia-ischaemia. We did a multicentre randomized controlled trial to find ou t if delayed head cooling can improve improved neurodevelopmental outcome in babies with neonatal encephalopathy. Methods: 234 term infants with moderate to severe neonat al encephalopathy and abnormal amplitude integrated electroencephalography (aEEG) were randomly assigned to either head cooling for 72 h, within 6 h of birth, w ith rectal temperature maintained at 34-35 ° C (n = 116), or conventional care (n = 118 Analysis was by intention to treat. We examined in two predefined subgroup analyzes the effec t of hypothermia in babies with the most severe aEEG changes before randomisatio n -ie, severe loss of background amplitude, and seizures-and those with less s evere changes. Findings: In 16 babies, follow-up data were not available. Thus in 218 infants (93%), 73/110 (66%) allo cated 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 chan ges with a logistic regression model, the odds ratio for hypothermia treatment w as 0.57 (0.32-1.01, p = 0.05). No difference was noted in the frequency of clinic ally important complications. Predefined subgroup analysis suggested that head c ooling 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) : These data suggest that althou gh 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.