Article Text

WHO IS EXCLUDED FROM HYPOTHERMIA TRIALS FOR NEONATAL ENCEPHALOPATHY?
  1. M A Boyle1,
  2. G S Harrison1,
  3. A Twomey1,
  4. P Davis1,2,
  5. E J Molloy1
  1. 1Neonatal Department, National Maternity Hospital, Holles Street, Dublin, Ireland
  2. 2Neonatal Department, the Royal Women’s Hospital, Carlton, Victoria, Australia

Abstract

Introduction Pooled analysis of eight randomised controlled trials (RCT) (n  =  638) shows that hypothermia for hypoxic ischaemic encephalopathy reduces the combined outcome of death or major disability and the individual outcomes of mortality and neurodevelopmental disability in survivors (1).

Aims To evaluate the number of infants with neonatal encephalopathy admitted to a large Irish perinatal centre who would have met the inclusion criteria for large RCT of cooling and define the excluded population.

Methods Retrospective chart review using the Holles Street neonatal encephalopathy database from January 2005 to September 2007. Each case was assessed using the individual trial criteria (1) and reasons for inclusion and/or exclusion were recorded.

Results 71 term infants had moderate or severe neonatal encephalopathy excluding major congenital abnormalities during the study period. Only 15 were eligible for individual hypothermia trials and four were excluded for the following reasons: two outborn and admitted >6 h of age, one predicted poor outcome, one chorioamnionitis. Fifty-six were ineligible due to delayed onset of abnormal neurological signs, transfer from peripheral hospital >6 h or insufficient clinical data. Therefore 11 (15.4%) infants would have been randomly assigned pending parental consent. Our findings contrast with an increased proportion of screened infants meeting inclusion criteria in large RCT.

Conclusion Hypothermia appears to be beneficial for the management of neonatal encephalopathy. However, significant numbers of our infants did not meet the inclusion criteria of the RCT, thus reducing the applicability of the trials and meta-analysis.

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