{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T21:23:47Z","timestamp":1777584227088,"version":"3.51.4"},"reference-count":28,"publisher":"American Academy of Pediatrics (AAP)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2008,10,1]]},"abstract":"<jats:p>BACKGROUND. Whole-body hypothermia reduced the frequency of death or moderate\/severe disabilities in neonates with hypoxic-ischemic encephalopathy in a randomized, controlled multicenter trial.<\/jats:p>\n               <jats:p>OBJECTIVE. Our goal was to evaluate outcomes of safety and effectiveness of hypothermia in infants up to 18 to 22 months of age.<\/jats:p>\n               <jats:p>DESIGN\/METHODS. A priori outcomes were evaluated between hypothermia (n = 102) and control (n = 106) groups.<\/jats:p>\n               <jats:p>RESULTS. Encephalopathy attributable to causes other than hypoxia-ischemia at birth was not noted. Inotropic support (hypothermia, 59% of infants; control, 56% of infants) was similar during the 72-hour study intervention period in both groups. Need for blood transfusions (hypothermia, 24%; control, 24%), platelet transfusions (hypothermia, 20%; control, 12%), and volume expanders (hypothermia, 54%; control, 49%) was similar in the 2 groups. Among infants with persistent pulmonary hypertension (hypothermia, 25%; control, 22%), nitric-oxide use (hypothermia, 68%; control, 57%) and placement on extracorporeal membrane oxygenation (hypothermia, 4%; control, 9%) was similar between the 2 groups. Non\u2013central nervous system organ dysfunctions occurred with similar frequency in the hypothermia (74%) and control (73%) groups. Rehospitalization occurred among 27% of the infants in the hypothermia group and 42% of infants in the control group. At 18 months, the hypothermia group had 24 deaths, 19 severe disabilities, and 2 moderate disabilities, whereas the control group had 38 deaths, 25 severe disabilities, and 1 moderate disability. Growth parameters were similar between survivors. No adverse outcomes were noted among infants receiving hypothermia with transient reduction of temperature below a target of 33.5\u00b0C at initiation of cooling. There was a trend in reduction of frequency of all outcomes in the hypothermia group compared with the control group in both moderate and severe encephalopathy categories.<\/jats:p>\n               <jats:p>CONCLUSIONS. Although not powered to test these secondary outcomes, whole-body hypothermia in infants with encephalopathy was safe and was associated with a consistent trend for decreasing frequency of each of the components of disability.<\/jats:p>","DOI":"10.1542\/peds.2008-0456","type":"journal-article","created":{"date-parts":[[2008,10,1]],"date-time":"2008-10-01T13:29:28Z","timestamp":1222867768000},"page":"e791-e798","source":"Crossref","is-referenced-by-count":163,"title":["Outcomes of Safety and Effectiveness in a Multicenter Randomized, Controlled Trial of Whole-Body Hypothermia for Neonatal Hypoxic-Ischemic Encephalopathy"],"prefix":"10.1542","volume":"122","author":[{"given":"Seetha","family":"Shankaran","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Athina","family":"Pappas","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Wayne State University School of Medicine, Detroit, Michigan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abbott R.","family":"Laptook","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Women and Infant's Hospital of Rhode Island, Providence, Rhode Island"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott A.","family":"McDonald","sequence":"additional","affiliation":[{"name":"Department of Statistics and Epidemiology, RTI International, Research Triangle Park, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard A.","family":"Ehrenkranz","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jon E.","family":"Tyson","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Texas Medical School at Houston, Houston, Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle","family":"Walsh","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Case Western University, Cleveland, Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald N.","family":"Goldberg","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Duke University, Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosemary D.","family":"Higgins","sequence":"additional","affiliation":[{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abhik","family":"Das","sequence":"additional","affiliation":[{"name":"Department of Statistics and Epidemiology, RTI International, Research Triangle Park, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"for the NICHD Neonatal Research Network","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"417","published-online":{"date-parts":[[2008,10,1]]},"reference":[{"key":"2021120902370698600_R1","doi-asserted-by":"crossref","unstructured":"Robertson CMT, Finer NN, Grace MGA. 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