The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial

Trials

Study Protocol

Christian Gluud¹  Janus Christian Jakobsen¹  Simon Hyttel-Sørensen²  Cornelia Hagmann³  Marie Isabel Rasmussen⁴  Gitte Holst Hahn⁴  Gorm Greisen⁴  Maria Linander Vestager⁴  Mathias Lühr Hansen⁵  Adelina Pellicer⁶  Siv Fredly⁷  Anne Marie Heuchan⁸  Gunnar Naulaers⁹  Jakub Tkaczyk^1,10  Gerhard Pichler^1,11  Hans Fuchs^1,12  Monica Fumagalli^1,13  Tomasz Szczapa^1,14  Eugene Dempsey^1,15  Gabriel Dimitriou^1,16  Saudamini Nesargi^1,17  Jonathan Mintzer^1,18 

[1] Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark;Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark;Department of Intensive Care, Copenhagen University Hospital – Rigshospitalet, Copenhagen, Denmark;Department of Neonatology, Children’s University Hospital of Zürich, Zurich, Switzerland;Department of Neonatology, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark;Department of Neonatology, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark;Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark;Department of Neonatology, La Paz University Hospital, Madrid, Spain;Department of Neonatology, Oslo University Hospital, Oslo, Norway;Department of Neonatology, Royal Hospital for Children, Glasgow, UK;Department of Neonatology, University Hospital Leuven, Louvain, Belgium;Department of Neonatology, University Hospital Motol, Prague, Czech Republic;Department of Pediatrics, Medical University of Graz, Graz, Austria;Division of Neonatology and Pediatric Intensive Care Medicine, Center for Pediatrics and Adolescents Medicine, Medical Center ─ University of Freiburg, Freiburg, Germany;Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico Milan, Milan, Italy;Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy;II Department of Neonatology, Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan, Poland;Infant Centre and Department of Paediatrics and Child Health, University College Cork, Cork, Ireland;NICU, Department of Paediatrics, University General Hospital of Patras, Patras, Greece;St. Johns Medical College Hospital, Bengaluru, India;The Department of Pediatrics, Division of Newborn Medicine, Mountainside Medical Center, Montclair, NJ, USA;

关键词: Randomised clinical trial;    Near infrared spectroscopy;    Protocol;    Mechanical ventilation;    Brain injury;   

DOI  :  10.1186/s13063-023-07699-x

 received in 2023-06-25, accepted in 2023-10-04,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to save newborn infants’ lives and brains or not. Newborns contribute heavily to total childhood mortality and neonatal brain damage is the cause of a large part of handicaps such as cerebral palsy. The objective of the SafeBoosC-IIIv trial is to evaluate the benefits and harms of cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns.Methods/designSafeBoosC-IIIv is an investigator-initiated, multinational, randomised, pragmatic phase-III clinical trial. The inclusion criteria will be newborns with a gestational age more than 28 + 0 weeks, postnatal age less than 28 days, predicted to require mechanical ventilation for at least 24 h, and prior informed consent from the parents or deferred consent or absence of opt-out. The exclusion criteria will be no available cerebral oximeter, suspicion of or confirmed brain injury or disorder, or congenital heart disease likely to require surgery.A total of 3000 participants will be randomised in 60 neonatal intensive care units from 16 countries, in a 1:1 allocation ratio to cerebral oximetry versus usual care. Participants in the cerebral oximetry group will undergo cerebral oximetry monitoring during mechanical ventilation in the neonatal intensive care unit for as long as deemed useful by the treating physician or until 28 days of life. The participants in the cerebral oximetry group will be treated according to the SafeBoosC treatment guideline. Participants in the usual care group will not receive cerebral oximetry and will receive usual care. We use two co-primary outcomes: (1) a composite of death from any cause or moderate to severe neurodevelopmental disability at 2 years of corrected age and (2) the non-verbal cognitive score of the Parent Report of Children’s Abilities-Revised (PARCA-R) at 2 years of corrected age.DiscussionThere is need for a randomised clinical trial to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns.Trial registrationThe protocol is registered at www.clinicaltrials.gov (NCT05907317; registered 18 June 2023).

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 1