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. |
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| 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 |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 41491571 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Rasmussen+MIS%22">Rasmussen MIS</searchLink>; Department of Neonatology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark. marie.isabel.skov.rasmussen@regionh.dk.<br /><searchLink fieldCode="AU" term="%22Hansen+ML%22">Hansen ML</searchLink>; Department of Neonatology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Pellicer+A%22">Pellicer A</searchLink>; Department of Neonatology, La Paz University Hospital, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Gluud+C%22">Gluud C</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Dempsey+E%22">Dempsey E</searchLink>; Infant Research Centre and Department of Paediatrics and Child Health, University College Cork, Cork, Ireland.<br /><searchLink fieldCode="AU" term="%22Mintzer+J%22">Mintzer J</searchLink>; Department of Pediatrics, Division of Newborn Medicine, Mountainside Medical Center, Montclair, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Hyttel-Sørensen+S%22">Hyttel-Sørensen S</searchLink>; Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Heuchan+AM%22">Heuchan AM</searchLink>; Department of Neonatology, Royal Hospital for Children, Glasgow, UK.<br /><searchLink fieldCode="AU" term="%22Hagmann+C%22">Hagmann C</searchLink>; Department of Neonatology, Children's University Hospital of Zürich, Zurich, Switzerland.<br /><searchLink fieldCode="AU" term="%22Ergenekon+E%22">Ergenekon E</searchLink>; Department of Neonatology, Gazi University Hospital, Yenimahalle, , Ankara, Turkey.<br /><searchLink fieldCode="AU" term="%22Dimitriou+G%22">Dimitriou G</searchLink>; NICU, Department of Pediatrics, University General Hospital of Patras, Patras, Greece.<br /><searchLink fieldCode="AU" term="%22Pichler+G%22">Pichler G</searchLink>; Department of Pediatrics, Medical University of Graz, Graz, Austria.<br /><searchLink fieldCode="AU" term="%22Naulaers+G%22">Naulaers G</searchLink>; Department of Neonatology, University Hospital Leuven, Louvain, Belgium.<br /><searchLink fieldCode="AU" term="%22Tkaczyk+J%22">Tkaczyk J</searchLink>; Department of Neonatology, University Hospital Motol, Prague, Czech Republic.<br /><searchLink fieldCode="AU" term="%22Fuchs+H%22">Fuchs H</searchLink>; Division of Neonatology and Pediatric Intensive Care Medicine, Center for Pediatrics and Adolescents Medicine, Medical Center-University of Freiburg, Freiburg, Germany.<br /><searchLink fieldCode="AU" term="%22Fumagalli+M%22">Fumagalli M</searchLink>; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Milan, Italy.; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Nesargi+S%22">Nesargi S</searchLink>; St. Johns Medical College Hospital, Bengaluru, India.<br /><searchLink fieldCode="AU" term="%22Fredly+S%22">Fredly S</searchLink>; Department of Neonatology, Oslo University Hospital, Oslo, Norway.<br /><searchLink fieldCode="AU" term="%22Szczapa+T%22">Szczapa T</searchLink>; II Department of Neonatology, Poznan University of Medical Sciences, Poznań, Poland.<br /><searchLink fieldCode="AU" term="%22Plomgaard+AM%22">Plomgaard AM</searchLink>; Department of Pediatrics, Hvidovre University Hospital, Hvidovre, Denmark.<br /><searchLink fieldCode="AU" term="%22Hansen+BM%22">Hansen BM</searchLink>; Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Hilleroed, Denmark.<br /><searchLink fieldCode="AU" term="%22Olsen+MH%22">Olsen MH</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Jakobsen+JC%22">Jakobsen JC</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Greisen+G%22">Greisen G</searchLink>; Department of Neonatology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22101263253%22">Trials</searchLink> [Trials] 2026 Jan 05; Vol. 27 (1), pp. 100. <i>Date of Electronic Publication: </i>2026 Jan 05. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Clinical Trial Protocol – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BioMed+Central%22">BioMed Central </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101263253 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1745-6215 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2217456215%22">17456215 </searchLink><i>NLM ISO Abbreviation: </i>Trials <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=41491571 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1186/s13063-025-09392-7 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 100 Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Rasmussen MIS – PersonEntity: Name: NameFull: Hansen ML – PersonEntity: Name: NameFull: Pellicer A – PersonEntity: Name: NameFull: Gluud C – PersonEntity: Name: NameFull: Dempsey E – PersonEntity: Name: NameFull: Mintzer J – PersonEntity: Name: NameFull: Hyttel-Sørensen S – PersonEntity: Name: NameFull: Heuchan AM – PersonEntity: Name: NameFull: Hagmann C – PersonEntity: Name: NameFull: Ergenekon E – PersonEntity: Name: NameFull: Dimitriou G – PersonEntity: Name: NameFull: Pichler G – PersonEntity: Name: NameFull: Naulaers G – PersonEntity: Name: NameFull: Tkaczyk J – PersonEntity: Name: NameFull: Fuchs H – PersonEntity: Name: NameFull: Fumagalli M – PersonEntity: Name: NameFull: Nesargi S – PersonEntity: Name: NameFull: Fredly S – PersonEntity: Name: NameFull: Szczapa T – PersonEntity: Name: NameFull: Plomgaard AM – PersonEntity: Name: NameFull: Hansen BM – PersonEntity: Name: NameFull: Olsen MH – PersonEntity: Name: NameFull: Jakobsen JC – PersonEntity: Name: NameFull: Greisen G IsPartOfRelationships: – BibEntity: Dates: – D: 05 M: 01 Text: 2026 Jan 05 Type: published Y: 2026 Identifiers: – Type: issn-electronic Value: 1745-6215 Numbering: – Type: volume Value: 27 – Type: issue Value: 1 Titles: – TitleFull: Trials Type: main |
| ResultId | 1 |
