Moderate hypothermia in neonatal encephalopathy: Safety outcomes

Dorothea J. Eicher, Carol L. Wagner, Lakshmi P. Katikaneni, Thomas C. Hulsey, W. Thomas Bass, David A. Kaufman, Michael J. Horgan, Sheila Languani, Jatinder J Bhatia, Lawrence M. Givelichian, Koravangatta Sankaran, Jerome Y. Yager

Research output: Contribution to journalArticle

202 Scopus citations

Abstract

Hypoxic-ischemic injury may cause multisystem organ damage with significant aberrations in clotting, renal, and cardiac functions. Systemic hypothermia may aggravate these medical conditions, such as bradycardia and increased clotting times, and very little safety data in neonatal hypoxic-ischemic injury is available. This study reports a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33°C) vs normothermia (37°C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event. The best outcome measures of safety were determined, comparing rates of adverse events between normothermia and hypothermia groups. A total of 32 hypothermia and 33 normothermia neonates were enrolled in seven centers. Adverse events and serious adverse effects were collected by the study team during the hospital admission, monitored by an independent study monitor, and reported to Institutional Review Boards and the Data and Safety Monitoring Committee. The following adverse events were observed significantly more commonly in the hypothermia group: more frequent bradycardia and lower heart rates during the period of hypothermia, longer dependence on pressors, higher prothrombin times, and lower platelet counts with more patients requiring plasma and platelet transfusions. Seizures as an adverse event were more common in the hypothermia group. These observed side effects of 48 hours of moderate systemic hypothermia were of mild to moderate severity and manageable with minor interventions.

Original languageEnglish (US)
Pages (from-to)18-24
Number of pages7
JournalPediatric Neurology
Volume32
Issue number1
DOIs
StatePublished - Jan 1 2005

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Neurology
  • Developmental Neuroscience
  • Clinical Neurology

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