Journal article
Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial
Archives of pediatrics & adolescent medicine, Vol.165(8), pp.692-700
08/2011
DOI: 10.1001/archpediatrics.2011.43
PMID: 21464374
Abstract
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.
Multicenter, international, randomized controlled trial.
Neonatal intensive care units in Australia, New Zealand, Canada, and the United States (N = 28) from February 2001 through July 2007.
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).
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.
Death or major sensorineural disability at 2 years of age.
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.
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.
anzctr.org.au Identifier: ACTRN12606000036516.
Details
- Title: Subtitle
- Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial
- Creators
- Susan E Jacobs - Neonatal Services, Royal Women's Hospital, Corner Grattan Street and Flemington Road, Parkville, Victoria 3052, Australia. sue.jacobs@thewomens.org.auColin J MorleyTerrie E InderMichael J StewartKatherine R SmithPatrick J McNamaraIan M R WrightHaresh M KirpalaniBrian A DarlowLex W DoyleInfant Cooling Evaluation Collaboration
- Resource Type
- Journal article
- Publication Details
- Archives of pediatrics & adolescent medicine, Vol.165(8), pp.692-700
- DOI
- 10.1001/archpediatrics.2011.43
- PMID
- 21464374
- NLM abbreviation
- Arch Pediatr Adolesc Med
- ISSN
- 1072-4710
- eISSN
- 1538-3628
- Publisher
- American Medical Association
- Language
- English
- Date published
- 08/2011
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology; Internal Medicine
- Record Identifier
- 9984093459402771
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