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Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy
Open accessAbstract
BACKGROUND: Hypothermia is protective against brain injury after asphyxiation in animal models. However, the safety and effectiveness of hypothermia in term infants with encephalopathy is uncertain. METHODS: We conducted a randomized trial of hypothermia in infants with a gestational age of at least 36 weeks who were admitted to the hospital at or before six hours of age with either severe acidosis or perinatal complications and resuscitation at birth and who had moderate or severe encephalopathy. Infants were randomly assigned to usual care (control group) or whole-body cooling to an esophageal temperature of 33.5 degrees C for 72 hours, followed by slow rewarming (hypothermia group). Neurodevelopmental outcome was assessed at 18 to 22 months of age. The primary outcome was a combined end point of death or moderate or severe disability. RESULTS: Of 239 eligible infants, 102 were assigned to the hypothermia group and 106 to the control group. Adverse events were similar in the two groups during the 72 hours of cooling. Primary outcome data were available for 205 infants. Death or moderate or severe disability occurred in 45 of 102 infants (44 percent) in the hypothermia group and 64 of 103 infants (62 percent) in the control group (risk ratio, 0.72; 95 percent confidence interval, 0.54 to 0.95; P=0.01). Twenty-four infants (24 percent) in the hypothermia group and 38 (37 percent) in the control group died (risk ratio, 0.68; 95 percent confidence interval, 0.44 to 1.05; P=0.08). There was no increase in major disability among survivors; the rate of cerebral palsy was 15 of 77 (19 percent) in the hypothermia group as compared with 19 of 64 (30 percent) in the control group (risk ratio, 0.68; 95 percent confidence interval, 0.38 to 1.22; P=0.20). CONCLUSIONS: Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.
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“Despite TH, some infants with HIE will exhibit poor long-term neurologic outcomes across a spectrum of severity including neurodevelopmental impairment (NDI) (3–6).”
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Metadata
- Authors
- Shankaran, S., Laptook, A. R., Ehrenkranz, R. A., Tyson, J. E., McDonald, S. A., Donovan, E. F., Fanaroff, A. A., Poole, W. K., Wright, L. L., Higgins, R. D., Finer, N. N., Carlo, W. A., Duara, S., Oh, W., Cotten, C. M., Stevenson, D. K., Stoll, B. J., Lemons, J. A., Guillet, R., & Jobe, A. H.
- Affiliations
- Wayne State University (US)
- Women & Infants Hospital of Rhode Island (US)
- Yale University (US)
- RTI International (US)
- University of Cincinnati (US)
- Rainbow Babies & Children's Hospital (US)
- National Institutes of Health (US)
- University of California San Diego (US)
- University of Alabama at Birmingham (US)
- University of Miami (US)
- Duke Medical Center (US)
- Stanford University (US)
- Emory University (US)
- Indiana University School of Medicine (US)
- University of Rochester (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2005-10-13
- Volume
- 353
- Issue
- 15
- Pages
- 1574-1584
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2164127547
- Cited by
- 2,862
- References
- 36
- Citations by year
- 2026: 95 · 2025: 152 · 2024: 157 · 2023: 121 · 2022: 118 · 2021: 155 · 2020: 123 · 2019: 129 · 2018: 152 · 2017: 152 · 2016: 143 · 2015: 170 · 2014: 131 · 2013: 141 · 2012: 166
- FWCI
- 89.20
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- Funders
- National Center for Research Resources (5-M01-RR-00044, M01RR008084, M01-RR00039, M01RR000125, M01-RR 00750, M01 RR-00125, M01 RR 0039-43, M01RR000750, M-01 RR 00070, M01RR000044, M01RR000070, M01RR000039, M01-RR-08084)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD040498, (U10 HD27871, U10 HD 27853, U10HD027880, U10 HD27880, U10 HD 40461, U10HD40521, U10HD21385, U10HD 21397, U10HD40498, U10HD27851, U10 HD34216, U10HD40492, U01HD36790, U10‐HD‐27904, U10HD021397, U10HD027904, U10HD027856, U10HD040689, U10HD027871, U10-HD21373, U10HD027853, U10HD040492, U10HD034216, U10HD021373, U10HD021385, U10HD40689, U10 HD27856, U10HD040521, U01HD036790, U10HD027851, U10HD040461)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Neonatal and fetal brain pathology
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Thermal Regulation in Medicine
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
- Keywords
- whole-body hypothermia, hypoxic-ischemic encephalopathy, neonates, neuroprotection, cerebral palsy, neurodevelopmental outcomes, perinatal asphyxia, acidosis, term infants, mortality, disability
- MeSH terms
- Acidosis, Asphyxia Neonatorum, Blindness, Cerebral Palsy, Developmental Disabilities, Female, Follow-Up Studies, Humans, Hypothermia, Induced, Infant, Newborn, Obstetric Labor Complications, Male, Pregnancy, Pregnancy Complications, Hypoxia-Ischemia, Brain, Hearing Loss
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