Cerebral oximetry monitoring versus usual care for extremely preterm infants: a detailed statistical analysis plan for the 2-year follow-up of the participants of the SafeBoosC-III randomised clinical trial.

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Title: Cerebral oximetry monitoring versus usual care for extremely preterm infants: a detailed statistical analysis plan for the 2-year follow-up of the participants of the SafeBoosC-III randomised clinical trial.
Authors: Rasmussen MIS; Department of Neonatology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark. marie.isabel.skov.rasmussen@regionh.dk., Hansen ML; Department of Neonatology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark., Pellicer A; Department of Neonatology, La Paz University Hospital, Madrid, Spain., Gluud C; Centre for Clinical Intervention Research, The Capital Region, Copenhagen Trial Unit, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark., Dempsey E; Infant Research Centre and Department of Paediatrics and Child Health, University College Cork, Cork, Ireland., Mintzer J; Department of Pediatrics, Division of Newborn Medicine, Mountainside Medical Center, Montclair, NJ, USA., Hyttel-Sørensen S; Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark., Heuchan AM; Department of Neonatology, Royal Hospital for Children, Glasgow, UK., Hagmann C; Department of Neonatology, Children's University Hospital of Zürich, Zurich, Switzerland., Ergenekon E; Department of Neonatology, Gazi University Hospital, Yenimahalle, , Ankara, Turkey., Dimitriou G; NICU, Department of Pediatrics, University General Hospital of Patras, Patras, Greece., Pichler G; Department of Pediatrics, Medical University of Graz, Graz, Austria., Naulaers G; Department of Neonatology, University Hospital Leuven, Louvain, Belgium., Tkaczyk J; Department of Neonatology, University Hospital Motol, Prague, Czech Republic., Fuchs H; Division of Neonatology and Pediatric Intensive Care Medicine, Center for Pediatrics and Adolescents Medicine, Medical Center-University of Freiburg, Freiburg, Germany., Fumagalli M; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy., Nesargi S; St. Johns Medical College Hospital, Bengaluru, India., Fredly S; Department of Neonatology, Oslo University Hospital, Oslo, Norway., Szczapa T; II Department of Neonatology, Poznan University of Medical Sciences, Poznań, Poland., Plomgaard AM; Department of Pediatrics, Hvidovre University Hospital, Hvidovre, Denmark., Hansen BM; Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Hilleroed, Denmark., Olsen MH; Centre for Clinical Intervention Research, The Capital Region, Copenhagen Trial Unit, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.; Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark., Jakobsen JC; Centre for Clinical Intervention Research, The Capital Region, Copenhagen Trial Unit, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark., Greisen G; Department of Neonatology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Source: Trials [Trials] 2026 Jan 05; Vol. 27 (1), pp. 100. Date of Electronic Publication: 2026 Jan 05.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1745-6215
DOI:10.1186/s13063-025-09392-7