Published online May 1, 2007
PEDIATRICS Vol. 119 No. 5 May 2007, pp. 912-921 (doi:10.1542/peds.2006-2839)
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ARTICLE

Determinants of Outcomes After Head Cooling for Neonatal Encephalopathy

John S. Wyatt, MBBSa, Peter D. Gluckman, FRSb, Ping Y. Liu, PhDc, Denis Azzopardi, MDd, Roberta Ballard, MDe, A. David Edwards, FMedScid, Donna M. Ferriero, MDf,g, Richard A. Polin, MDh, Charlene M. Robertson, MDi, Marianne Thoresen, MD, PhDj, Andrew Whitelaw, MDk, Alistair J. Gunn, MBChB, PhDl for the CoolCap Study Group

a Department of Paediatrics and Child Health, University College London, London, United Kingdom
b The Liggins Institute
l Department of Physiology, University of Auckland, Auckland, New Zealand
c Drug and Device Development Company, Redmond, Washington
d Division of Clinical Sciences, Imperial College, London, United Kingdom
e Department of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania
f Departments of Neurology
g Pediatrics, University of California, San Francisco, San Francisco, California
h College of Physicians and Surgeons, Columbia University, New York, New York
i Department of Pediatrics, University of Alberta, Edmonton, Canada
j Department of Clinical Science, St Michael's Hospital
k Department of Clinical Science, Southmead Hospital, University of Bristol, Bristol, United Kingdom

OBJECTIVE. The goal of this study was to evaluate the role of factors that may determine the efficacy of treatment with delayed head cooling and mild systemic hypothermia for neonatal encephalopathy.

METHODS. A total of 218 term infants with moderate to severe neonatal encephalopathy plus abnormal amplitude-integrated electroencephalographic recordings, assigned randomly to head cooling for 72 hours, starting within 6 hours after birth (with the rectal temperature maintained at 34.5 ± 0.5°C), or conventional care, were studied. Death or severe disability at 18 months of age was assessed in a multicenter, randomized, controlled study (the CoolCap trial).

RESULTS. Treatment, lower encephalopathy grade, lower birth weight, greater amplitude-integrated electroencephalographic amplitude, absence of seizures, and higher Apgar score, but not gender or gestational age, were associated significantly with better outcomes. In a multivariate analysis, each of the individually predictive factors except for Apgar score remained predictive. There was a significant interaction between treatment and birth weight, categorized as ≥25th or <25th percentile for term, such that larger infants showed a lower frequency of favorable outcomes in the control group but greater improvement with cooling. For larger infants, the number needed to treat was 3.8. Pyrexia (≥38°C) in control infants was associated with adverse outcomes. Although there was a small correlation with birth weight, the adverse effect of greater birth weight in control infants remained significant after adjustment for pyrexia and severity of encephalopathy.

CONCLUSIONS. Outcomes after hypothermic treatment were strongly influenced by the severity of neonatal encephalopathy. The protective effect of hypothermia was greater in larger infants.

Key Words: neonatal encephalopathy • hypoxic/ischemic encephalopathy • induced hypothermia • birth weight • pyrexia

Abbreviations: aEEG—amplitude-integrated electroencephalography • OR—odds ratio • CI—confidence interval

Accepted Dec 29, 2006.




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