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Previous Volume 361:1349-1358 October 1, 2009 Number 14 Next

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ABSTRACT

Background Whether hypothermic therapy improves neurodevelopmental outcomes in newborn infants with asphyxial encephalopathy is uncertain.

Methods We performed a randomized trial of infants who were less than 6 hours of age and had a gestational age of at least 36 weeks and perinatal asphyxial encephalopathy. We compared intensive care plus cooling of the body to 33.5°C for 72 hours and intensive care alone. The primary outcome was death or severe disability at 18 months of age. Prespecified secondary outcomes included 12 neurologic outcomes and 14 other adverse outcomes.

Results Of 325 infants enrolled, 163 underwent intensive care with cooling, and 162 underwent intensive care alone. In the cooled group, 42 infants died and 32 survived but had severe neurodevelopmental disability, whereas in the noncooled group, 44 infants died and 42 had severe disability (relative risk for either outcome, 0.86; 95% confidence interval [CI], 0.68 to 1.07; P=0.17). Infants in the cooled group had an increased rate of survival without neurologic abnormality (relative risk, 1.57; 95% CI, 1.16 to 2.12; P=0.003). Among survivors, cooling resulted in reduced risks of cerebral palsy (relative risk, 0.67; 95% CI, 0.47 to 0.96; P=0.03) and improved scores on the Mental Developmental Index and Psychomotor Developmental Index of the Bayley Scales of Infant Development II (P=0.03 for each) and the Gross Motor Function Classification System (P=0.01). Improvements in other neurologic outcomes in the cooled group were not significant. Adverse events were mostly minor and not associated with cooling.

Conclusions Induction of moderate hypothermia for 72 hours in infants who had perinatal asphyxia did not significantly reduce the combined rate of death or severe disability but resulted in improved neurologic outcomes in survivors. (Current Controlled Trials number, ISRCTN89547571 [controlled-trials.com] .)

Source Information

From the Division of Clinical Sciences and Medical Research Council (MRC) Clinical Sciences Centre, Hammersmith Hospital, Imperial College London, London (D.V.A., A.D.E., L.D., O.K., E.P.); the National Perinatal Epidemiology Unit, University of Oxford, Oxford (B.S., E.J., P.B.); the Department of Perinatal Medicine, Royal Maternity Hospital and Department of Child Health, Queen's University, Belfast (H.L.H.); the University of Leeds and Leeds General Infirmary, Leeds (M.L.); the Academic Division of Child Health, Queen's Medical Centre, Nottingham (N.M.); and the Department of Clinical Science, University of Bristol, St. Michael's Hospital (M.T.) and Southmead Hospital (A.W.), Bristol — all in the United Kingdom.

Address reprint requests to Dr. Azzopardi at the Division of Clinical Sciences and MRC Clinical Sciences Centre, Imperial College London, Hammersmith Hospital, Du Cane Rd., London W12 0NN, United Kingdom, or at d.azzopardi{at}imperial.ac.uk.

Full Text of this Article

This article has been cited by other articles:

• (2009). Does Hypothermia Lead to Better Outcomes in Newborns with Asphyxial Encephalopathy?. JWatch Pediatrics 2009: 1-1 [Full Text]  
• (2009). All you need to read in the other general journals. BMJ 339: b4054-b4054 [Full Text]