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Treatment guided by cerebral oximetry in mechanically ventilated newborns: a statistical analysis plan for step one of the SafeBoosC-IIIv randomised clinical trial.

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Title: Treatment guided by cerebral oximetry in mechanically ventilated newborns: a statistical analysis plan for step one of the SafeBoosC-IIIv randomised clinical trial.
Authors: Petersen JJ; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark. johanne.juul.petersen@ctu.dk., Kamp CB; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark., Olsen MH; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark.; Department of Neuroanaesthesiology, Neuroscience Centre, The Capital Region, Copenhagen, Denmark., Hansen ML; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark.; Department of Neonatology, Copenhagen, Denmark., Thorlund K; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada., Pellicer A; Department of Neonatology, La Paz University Hospital, Hospital La Paz Institute for Health Research-IdIPAZ, Madrid, Spain., Naulaers G; University Hospital Leuven, Louvain, Belgium., Dempsey E; Infant Research Centre, University College Cork, Cork, Ireland., Hahn GH; Department of Neonatology, Copenhagen, Denmark., Andersen PB; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark., Rasmussen MIS; Department of Neonatology, Copenhagen, Denmark., Pichler G; Division of Neonatology, Department of Pediatrics and Adolescence Medicine, Medical University Graz, Graz, Austria., Dimitriou G; University of Patras, General Hospital, Rio, Greece., Szczapa T; II Department of Neonatology, Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan, Poland., Ognean ML; Faculty of Medicine, Lucian Blaga University Sibiu, Sibiu, Romania.; Department of Neonatology, Clinical County Emergency Hospital Sibiu, Sibiu, Romania., Nesargi S; St John's Medical College Hospital, Bengaluru, Karnataka, India., Musante G; Hospital Universitario Austral, Pilar, Argentina., Chalak L; UT Southwestern Medical Center, Dallas, USA., Di Maio M; CHU Nîmes, Nîmes, France., Lakhwani J; Women and Newborn Hospital, University Teaching Hospitals, Lusaka, Zambia., Procianoy RS; Hospital de Clínicas de Porto Alegre, Universidade Federal Do Rio Grande Do Sul, Porto Alegre, Brazil., Tkaczyk J; University Hospital Motol, Prague, Czech Republic., Fuchs H; Medical Center, University of Freiburg, Freiburg, Germany., Cetinkaya M; Department of Neonatology, Health Sciences University, Basaksehir Cam and Sakura City Hospital, İstanbul, Türkiye., Hagmann C; Department of Neonatology and Intensive Care, University Children's Hospital Zürich, Zurich, Switzerland., Popat H; Grace Centre for Newborn Intensive Care in The Children's Hospital at Westmead, Sydney, Australia.; NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia., Fabres J; Department of Pediatrics, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.; Red de Salud UC Christus, Santiago, Chile., Wang L; National Health Commission Key Laboratory of Neonatal Diseases, Children's Hospital of Fudan University, Shanghai, China., Schmölzer G; Department of Pediatrics, University of Alberta, Edmonton, Canada., Piris-Borregas S; Hospital Universitario 12 de Octubre, Madrid, Spain., Mohora R; The National Institute for Mother and Child Care Alessandrescu-Rusescu, Polizu Maternity, București, Romania., Zafra P; Hospital Universitario Puerta del Mar, Cádiz, Spain., Sarafidis K; Ippokrateion General Hospital of Thessaloniki, Thessaloniki, Greece., Alsina-Casanova M; Department of Neonatology, Hospital Clínic Barcelona, BCNatal-Barcelona Center for Maternal-Fetal and Neonatal Medicine, Barcelona, Spain., Baik-Schneditz N; Division of Neonatology, Department of Pediatrics and Adolescence Medicine, Medical University Graz, Graz, Austria., Lopez LS; Hospital Universitario Virgen Las Nieves, Granada, Spain., Griesmaier E; Department of Pediatrics II, Medical University of Innsbruck, Innsbruck, Austria., Hatzidaki E; University Hospital of Heraklion, Heraklion, Greece., Shashidhar A; St John's Medical College Hospital, Bengaluru, Karnataka, India., Dassios T; University of Patras, General Hospital, Rio, Greece., Arruza L; Hospital Clinico San Carlos-IdISSC, Madrid, Spain., Greisen G; Department of Neonatology, Copenhagen, Denmark.; Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Jakobsen JC; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark.; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
Source: Trials [Trials] 2025 Dec 18; Vol. 27 (1), pp. 72. Date of Electronic Publication: 2025 Dec 18.
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
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  Data: Treatment guided by cerebral oximetry in mechanically ventilated newborns: a statistical analysis plan for step one of the SafeBoosC-IIIv randomised clinical trial.
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  Data: <searchLink fieldCode="AU" term="%22Petersen+JJ%22">Petersen JJ</searchLink>; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark. johanne.juul.petersen@ctu.dk.<br /><searchLink fieldCode="AU" term="%22Kamp+CB%22">Kamp CB</searchLink>; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Olsen+MH%22">Olsen MH</searchLink>; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark.; Department of Neuroanaesthesiology, Neuroscience Centre, The Capital Region, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Hansen+ML%22">Hansen ML</searchLink>; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark.; Department of Neonatology, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Thorlund+K%22">Thorlund K</searchLink>; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.<br /><searchLink fieldCode="AU" term="%22Pellicer+A%22">Pellicer A</searchLink>; Department of Neonatology, La Paz University Hospital, Hospital La Paz Institute for Health Research-IdIPAZ, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Naulaers+G%22">Naulaers G</searchLink>; University Hospital Leuven, Louvain, Belgium.<br /><searchLink fieldCode="AU" term="%22Dempsey+E%22">Dempsey E</searchLink>; Infant Research Centre, University College Cork, Cork, Ireland.<br /><searchLink fieldCode="AU" term="%22Hahn+GH%22">Hahn GH</searchLink>; Department of Neonatology, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Andersen+PB%22">Andersen PB</searchLink>; Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Rasmussen+MIS%22">Rasmussen MIS</searchLink>; Department of Neonatology, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22Pichler+G%22">Pichler G</searchLink>; 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Department of Neonatology and Intensive Care, University Children's Hospital Zürich, Zurich, Switzerland.<br /><searchLink fieldCode="AU" term="%22Popat+H%22">Popat H</searchLink>; Grace Centre for Newborn Intensive Care in The Children's Hospital at Westmead, Sydney, Australia.; NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.<br /><searchLink fieldCode="AU" term="%22Fabres+J%22">Fabres J</searchLink>; Department of Pediatrics, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.; Red de Salud UC Christus, Santiago, Chile.<br /><searchLink fieldCode="AU" term="%22Wang+L%22">Wang L</searchLink>; National Health Commission Key Laboratory of Neonatal Diseases, Children's Hospital of Fudan University, Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Schmölzer+G%22">Schmölzer G</searchLink>; Department of Pediatrics, University of Alberta, Edmonton, Canada.<br /><searchLink fieldCode="AU" term="%22Piris-Borregas+S%22">Piris-Borregas S</searchLink>; Hospital Universitario 12 de Octubre, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Mohora+R%22">Mohora R</searchLink>; The National Institute for Mother and Child Care Alessandrescu-Rusescu, Polizu Maternity, București, Romania.<br /><searchLink fieldCode="AU" term="%22Zafra+P%22">Zafra P</searchLink>; Hospital Universitario Puerta del Mar, Cádiz, Spain.<br /><searchLink fieldCode="AU" term="%22Sarafidis+K%22">Sarafidis K</searchLink>; Ippokrateion General Hospital of Thessaloniki, Thessaloniki, Greece.<br /><searchLink fieldCode="AU" term="%22Alsina-Casanova+M%22">Alsina-Casanova M</searchLink>; Department of Neonatology, Hospital Clínic Barcelona, BCNatal-Barcelona Center for Maternal-Fetal and Neonatal Medicine, Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Baik-Schneditz+N%22">Baik-Schneditz N</searchLink>; Division of Neonatology, Department of Pediatrics and Adolescence Medicine, Medical University Graz, Graz, Austria.<br /><searchLink fieldCode="AU" term="%22Lopez+LS%22">Lopez LS</searchLink>; 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Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region of Denmark, Copenhagen, Denmark.; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.
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