Document Detail


Whole-Body Hypothermia for Term and Near-Term Newborns With Hypoxic-Ischemic Encephalopathy: A Randomized Controlled Trial.
MedLine Citation:
PMID:  21464374     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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. DESIGN: Multicenter, international, randomized controlled trial. SETTING: Neonatal intensive care units in Australia, New Zealand, Canada, and the United States (N = 28) from February 2001 through July 2007. PARTICIPANTS: 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). Intervention  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. MAIN OUTCOME MEASURES: 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. Trial Registration  anzctr.org.au Identifier: ACTRN12606000036516.
Authors:
Susan E Jacobs; Colin J Morley; Terrie E Inder; Michael J Stewart; Katherine R Smith; Patrick J McNamara; Ian M R Wright; Haresh M Kirpalani; Brian A Darlow; Lex W Doyle;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-4-4
Journal Detail:
Title:  Archives of pediatrics & adolescent medicine     Volume:  -     ISSN:  1538-3628     ISO Abbreviation:  -     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-4-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9422751     Medline TA:  Arch Pediatr Adolesc Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Royal Women's Hospital (Drs Jacobs, Morley, Stewart, and Doyle), the Newborn Emergency Transport Service (Drs Jacobs and Stewart), Departments of Obstetrics and Gynaecology (Drs Morley and Doyle) and Paediatrics (Dr Doyle), University of Melbourne, the Neonatal Department, Royal Children's Hospital (Dr Stewart), and the Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute (Ms Smith), Melbourne, and Kaleidoscope Neonatal Intensive Care Unit, John Hunter Children's Hospital and Hunter Medical Research Institute, Newcastle (Dr Wright), Australia; Departments of Pediatrics, Radiology, and Neurology, St Louis Children's Hospital, Washington University, St Louis, Missouri (Dr Inder), and Division of Neonatalogy, Children's Hospital of Philadelphia, Pennsylvania (Dr Kirpalani); Division of Neonatology, Hospital for Sick Children, Toronto, Ontario, Canada (Dr McNamara), and Department of Clinical Epidemiology, McMaster Children's Hospital, Hamilton, Ontario, Canada (Dr Kirpalani); and Department of Paediatrics, Christchurch School of Medicine and Health Sciences, University of Otago, Christchurch, New Zealand (Dr Darlow).
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