{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T18:04:09Z","timestamp":1784311449220,"version":"3.55.0"},"reference-count":26,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Pediatr"],"published-print":{"date-parts":[[2026,6,1]]},"abstract":"\n Importance<\/jats:title>\n Cerebral oximetry monitoring in the first 72 hours after birth has not been shown to reduce death or severe brain injury at 36 weeks\u2019 postmenstrual age in extremely preterm infants. The long-term effects remain uncertain.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To determine whether treatment guided by cerebral oximetry monitoring during the first 72 hours after birth reduces the risk of death or longer-term neurodevelopmental outcomes at 2 years\u2019 corrected age, compared with usual care.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n In the phase 3 Safeguarding the Brain of Our Smallest Children (SafeBoosC-III) randomized clinical trial, we compared treatment guided by cerebral oximetry monitoring with usual care for the first 72 hours after birth. Seventy sites across 17 countries randomized 1601 infants within 6 hours of birth. Infants from 56 sites participated in this follow-up. Blinded assessors evaluated outcomes using a predefined 3-tier data model combining formal clinical assessments, parental questionnaires, and informal assessments. Data were analyzed from October to December 2024.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Treatment guided by cerebral oximetry monitoring for the first 72 hours after birth vs usual care.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The coprimary outcomes were as follows: (1) death or moderate or severe neurodevelopmental disability and (2) Bayley cognitive composite score, both assessed at approximately 2 years\u2019 corrected age.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 1438 infants (mean [SD] age, 26.0 [1.3] weeks; 758 male [52.7%]) participated in this follow-up study. Participants were followed up from October 2021 to October 2024. Death or moderate or severe neurodevelopmental disability occurred in 292 of 620 infants (47.1%) in the cerebral oximetry group compared with 321 of 669 infants (48.0%) in the usual-care group (relative risk with cerebral oximetry, 0.96; 97.5% CI, 0.85-1.07;\n P<\/jats:italic>\n \u2009=\u2009.45). The mean (SD) Bayley cognitive score was 92.8 (17.0) in the cerebral oximetry group compared with 93.2 (17.3) in the usual-care group (mean difference with cerebral oximetry, \u22120.14; 97.5% CI, \u22123.24 to 2.96;\n P<\/jats:italic>\n \u2009=\u2009.92).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In extremely preterm infants, treatment guided by cerebral oximetry monitoring compared with usual care for the first 72 hours after birth did not result in a lower incidence of death or moderate or severe neurodevelopmental disability nor higher Bayley cognitive scores at 2 years\u2019 corrected age. The routine use of cerebral oximetry monitoring during the first 72 hours after birth in extremely preterm infants to reduce neurodevelopmental disability was not supported by this trial.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05134116<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamapediatrics.2026.1066","type":"journal-article","created":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T15:30:41Z","timestamp":1776699041000},"page":"619","source":"Crossref","is-referenced-by-count":1,"title":["Cerebral Oximetry in Extremely Preterm Infants"],"prefix":"10.1001","volume":"180","author":[{"given":"Marie Isabel Skov","family":"Rasmussen","sequence":"first","affiliation":[{"name":"Department of Neonatology, Copenhagen University Hospital\u2013Rigshospitalet, Copenhagen, Denmark"},{"name":"Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital\u2013Rigshospitalet, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathias L.","family":"Hansen","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Copenhagen University Hospital\u2013Rigshospitalet, Copenhagen, Denmark"},{"name":"Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital\u2013Rigshospitalet, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adelina","family":"Pellicer","sequence":"additional","affiliation":[{"name":"Department of Neonatology, La Paz University Hospital, Madrid, Spain"},{"name":"Hospital La Paz Institute for Health Research-IdiPAZ, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Hyttel-S\u00f8rensen","sequence":"additional","affiliation":[{"name":"Department of Intensive Care, Copenhagen University Hospital\u2013Rigshospitalet, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ebru","family":"Ergenekon","sequence":"additional","affiliation":[{"name":"Division of Newborn Medicine, Gazi University Hospital, Ankara, Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomasz","family":"Szczapa","sequence":"additional","affiliation":[{"name":"2nd Department of Neonatology, Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Chair of Neonatology, Poznan University of Medical Sciences, Poznan, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelia","family":"Hagmann","sequence":"additional","affiliation":[{"name":"Pediatric Intensive Care and Neonatology, Children\u2019s University Hospital of Zurich, Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gunnar","family":"Naulaers","sequence":"additional","affiliation":[{"name":"Department of Development and Regeneration, KU Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Mintzer","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Newborn Medicine, Mountainside Medical Center, Montclair, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Fumagalli","sequence":"additional","affiliation":[{"name":"Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, Milan, Italy"},{"name":"Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriel","family":"Dimitriou","sequence":"additional","affiliation":[{"name":"NICU, Department of Pediatrics, Patras Medical School, Patras, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eugene","family":"Dempsey","sequence":"additional","affiliation":[{"name":"Infant Centre and Department of Paediatrics and Child Health, University College Cork, Cork, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jakub","family":"Tkaczyk","sequence":"additional","affiliation":[{"name":"Department of Neonatology, University Hospital Motol, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siv","family":"Fredly","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Oslo University Hospital, Oslo, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne M.","family":"Heuchan","sequence":"additional","affiliation":[{"name":"Department of Neonatal Medicine, Royal Hospital for Children, Glasgow, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerhard","family":"Pichler","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Medical University of Graz, Graz, Austria"},{"name":"Research Unit for Neonatal Micro- and Macrocirculation, Medical University of Graz, Graz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans","family":"Fuchs","sequence":"additional","affiliation":[{"name":"Division of Neonatology and Pediatric Intensive Care Medicine, Center for Pediatrics and Adolescents Medicine, Medical Center - University of Freiburg, Freiburg, Germany"},{"name":"Faculty of Medicine, University of Freiburg, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saudamini","family":"Nesargi","sequence":"additional","affiliation":[{"name":"Department of Neonatology, St John\u2019s Medical College, Bangalore, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gitte H.","family":"Hahn","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Copenhagen University Hospital\u2013Rigshospitalet, Copenhagen, 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