title: Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial.
abstract: OBJECTIVE
  To determine the effectiveness and safety of moderate whole-body hypothermia in newborns with hypoxic-ischemic encephalopathy born in hospitals with and without newborn intensive care facilities or complicated hypothermia equipment.
  
  
  METHODS
  Multicenter, international, randomized controlled trial.
  
  
  METHODS
  Neonatal intensive care units in Australia, New Zealand, Canada, and the United States (N = 28) from February 2001 through July 2007.
  
  
  METHODS
  Newborns of 35 weeks' gestation or more, with indicators of peripartum hypoxia-ischemia and moderate to severe clinical encephalopathy, randomly allocated to hypothermia (n = 110) or standard care (n = 111).
  
  
  METHODS
  Whole-body hypothermia to 33.5°C for 72 hours or standard care (37°C). Infants who received hypothermia were treated at ambient environmental temperature by turning off the radiant warmer and then applying refrigerated gel packs to maintain rectal temperature at 33°C to 34°C.
  
  
  METHODS
  Death or major sensorineural disability at 2 years of age.
  
  
  RESULTS
  Therapeutic hypothermia reduced the risk of death or major sensorineural disability at 2 years of age: 55 of 107 infants (51.4%) in the hypothermia group and 67 of 101 infants (66.3%) in the control group died or had a major sensorineural disability at 2 years (risk ratio, 0.77 [95% confidence interval, 0.62-0.98]; P = .03). The mortality rate decreased, and the survival rate free of any sensorineural disability increased. Adverse effects of hypothermia were minimal.
  
  
  CONCLUSIONS
  Whole-body hypothermia is effective and appears to be safe when commenced within 6 hours of birth at the hospital of birth in term and near-term newborns with hypoxic-ischemic encephalopathy. This simple method of hypothermia could be used within strict protocols with appropriate training on correct diagnosis and application of hypothermia in nontertiary neonatal settings while awaiting retrieval and transport to the regional neonatal intensive care unit.
  
  
  BACKGROUND
  anzctr.org.au Identifier: ACTRN12606000036516.
authors.affiliation: Neonatal Services, Royal Women's Hospital, Corner Grattan Street and Flemington Road, Parkville, Victoria 3052, Australia. sue.jacobs@thewomens.org.au
authors.forename: Susan E
authors.initials: SE
authors.lastname: Jacobs
authors.forename: Colin J
authors.initials: CJ
authors.lastname: Morley
authors.forename: Terrie E
authors.initials: TE
authors.lastname: Inder
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Stewart
authors.forename: Katherine R
authors.initials: KR
authors.lastname: Smith
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: McNamara
authors.forename: Ian M R
authors.initials: IM
authors.lastname: Wright
authors.forename: Haresh M
authors.initials: HM
authors.lastname: Kirpalani
authors.forename: Brian A
authors.initials: BA
authors.lastname: Darlow
authors.forename: Lex W
authors.initials: LW
authors.lastname: Doyle
mesh_terms: D001315:Australia / Q000453:epidemiology; D002170:Canada / Q000453:epidemiology; D002547:Cerebral Palsy / Q000453:epidemiology / Q000209:etiology; D002658:Developmental Disabilities / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects / Q000379:methods*; D020925:Hypoxia-Ischemia, Brain / Q000150:complications / Q000401:mortality / Q000628:therapy*; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D008297:Male; D009520:New Zealand / Q000453:epidemiology; D012044:Regression Analysis; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology