{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,25]],"date-time":"2026-10-25T01:31:06Z","timestamp":1792891866132,"version":"4.5.0"},"reference-count":27,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Pediatr"],"published-print":{"date-parts":[[2025,4,1]]},"abstract":"Importance<\/jats:title>Hypothermia begun less than 6 hours after birth reduces death or disability in infants with encephalopathy due to hypoxia-ischemia at 36 or more weeks\u2019 gestation. Trials of hypothermia for infants younger than 36 weeks\u2019 gestation are lacking.<\/jats:p><\/jats:sec>Objective<\/jats:title>To assess the probability that hypothermia at less than 6 hours after birth decreases death or disability in infants 33 to 35 weeks\u2019 gestation with moderate or severe hypoxic-ischemic encephalopathy.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>This randomized clinical trial was conducted between July 2015 and December 2022 for infants 33 to 35 weeks\u2019 gestation with moderate or severe hypoxic-ischemic encephalopathy at less than 6 hours after birth. Bayesian and intention-to-treat analyses were prespecified. The setting included 19 US Neonatal Research Network centers. Data were analyzed from March 2023 to November 2024.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Infants received unblinded targeted esophageal temperature management. Infants with hypothermia were maintained at 33.5 \u00b0C (acceptable 33-34 \u00b0C) for 72 hours and then rewarmed. Infants with normothermia were to be maintained at 37 \u00b0C (acceptable 36.5-37.3 \u00b0C).<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>Composite of death or disability (moderate or severe) at 18 to 22 months\u2019 corrected age adjusted for level of encephalopathy and center.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 168 infants with hypothermia and normothermia were preterm (mean [SD] age, 34.0 [0.8] weeks\u2019 gestation and 34.1 [0.8] weeks\u2019 gestation, respectively), while 46 of 88 (52%) and 45 of 80 (56%) were male, respectively. Randomization occurred at mean (SD) 4.5 (1.2) hours and 4.5 (1.3) hours for the groups with hypothermia and normothermia, respectively. The primary outcome occurred in 29 of 83 infants (35%) with hypothermia and 20 of 69 infants (29%) with normothermia (adjusted relative risk [hypothermic\/normothermic], 1.11; 95% credibility interval, 0.74-2.00), and death occurred in 18 of 88 infants (20%) with hypothermia and 9 of 78 infants (12%) with normothermia (adjusted relative risk, 1.38; 95% credibility interval, 0.79-2.85). Bayesian analysis with neutral prior indicated 74% probability of increased death or disability and 87% probability of increased death with hypothermia.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>Among infants 33 to 35 weeks\u2019 gestation with hypoxic-ischemic encephalopathy, hypothermia at less than 6 hours\u2019 age did not reduce death or disability at 18 to 22 months\u2019 corrected age.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT01793129<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamapediatrics.2024.6613","type":"journal-article","created":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T16:33:32Z","timestamp":1740414812000},"page":"396","source":"Crossref","is-referenced-by-count":50,"title":["Whole-Body Hypothermia for Neonatal Encephalopathy in Preterm Infants 33 to 35 Weeks\u2019 Gestation"],"prefix":"10.1001","volume":"179","author":[{"given":"Roger G.","family":"Faix","sequence":"first","affiliation":[{"name":"Division of Neonatology, Department of Pediatrics, University of Utah Health Sciences Center, University of Utah, Salt Lake City, Utah"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abbot R.","family":"Laptook","sequence":"additional","affiliation":[{"name":"Women and Infants Hospital of Rhode Island, Brown University, Providence, Rhode Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seetha","family":"Shankaran","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital of Michigan and Hutzel Women\u2019s Hospital, Wayne State University, Detroit"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry","family":"Eggleston","sequence":"additional","affiliation":[{"name":"Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North 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