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

Abstract Background Newborns requiring invasive mechanical ventilation are at high risk of neurodevelopmental impairment, prolonged hospitalisation, and increased mortality. Treatment guided by cerebral oximetry monitoring has been proposed to reduce morbidity and mortality. Methods The SafeBoosC-II...

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Principais autores:	Johanne Juul Petersen, Caroline Barkholt Kamp, Markus Harboe Olsen, Mathias Lühr Hansen, Kristian Thorlund, Adelina Pellicer, Gunnar Naulaers, Eugene Dempsey, Gitte Holst Hahn, Patrick Bjerregaard Andersen, Marie Isabel Skov Rasmussen, Gerhard Pichler, Gabriel Dimitriou, Tomasz Szczapa, Maria Livia Ognean, Saudamini Nesargi, Gabriel Musante, Lina Chalak, Massimo Di Maio, Jyoti Lakhwani, Renato S. Procianoy, Jakub Tkaczyk, Hans Fuchs, Merih Cetinkaya, Cornelia Hagmann, Himanshu Popat, Jorge Fabres, Laishuan Wang, Georg Schmölzer, Salvador Piris-Borregas, Ramona Mohora, Pamela Zafra, Kosmas Sarafidis, Miguel Alsina-Casanova, Nariae Baik-Schneditz, Laura Serrano Lopez, Elke Griesmaier, Eleftheria Hatzidaki, A. Shashidhar, Theodore Dassios, Luis Arruza, Gorm Greisen, Janus Christian Jakobsen
Formato:	Artigo
Idioma:	Inglês
Publicado:	BMC 2025-12-01
Series:	Trials
Assuntos:	Randomised clinical trial Statistics Neonatology Cerebral oximetry monitoring Mechanical ventilation
Acceso en liña:	https://doi.org/10.1186/s13063-025-09387-4
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