Cerebral oximetry monitoring versus usual care for extremely preterm infants: a study protocol for the 2-year follow-up of the SafeBoosC-III randomised clinical trial

Trials

Study Protocol

Christian Gluud¹  Janus Christian Jakobsen¹  Simon Hyttel-Sørensen²  Guoqiang Cheng³  Cornelia Hagmann⁴  Marie Isabel Rasmussen⁵  Gorm Greisen⁵  Mathias Lühr Hansen⁶  Ebru Ergenekon⁷  Adelina Pellicer⁸  Siv Fredly⁹  Anne Marie Heuchan^1,10  Gunnar Naulaers^1,11  Jakub Tkaczyk^1,12  Bo Mølholm Hansen^1,13  Anne Mette Plomgaard^1,14  Jonathan Mintzer^1,15  Gerhard Pichler^1,16  Gabriel Dimitriou^1,17  Hans Fuchs^1,18  Monica Fumagalli^1,19  Tomasz Szczapa^2,20  Eugene Dempsey^2,21  Saudamini Nesargi^2,22 

[1] Centre for Clinical Intervention Research, Copenhagen Trial Unit, 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 Hospital of Fudan University, Shanghai, China;Department of Neonatology, Children’s University Hospital of Zürich, Zurich, Switzerland;Department of Neonatology, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark;Department of Neonatology, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark;Centre for Clinical Intervention Research, Copenhagen Trial Unit, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark;Department of Neonatology, Gazi University Hospital, Yenimahalle, Ankara, Turkey;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 Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Hilleroed, Denmark;Department of Pediatrics, Copenhagen University Hospital, Hvidovre, Denmark;Department of Pediatrics, Division of Newborn Medicine, Mountainside Medical Center, Montclair, NJ, USA;Department of Pediatrics, Medical University of Graz, Graz, Austria;Department of Pediatrics, NICU, University General Hospital of Patras, Patras, Greece;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, Poznan University of Medical Sciences, Poznań, Poland;Infant Research Centre and Department of Paediatrics and Child Health, University College Cork, Cork, Ireland;St. Johns Medical College Hospital, Bengaluru, India;

关键词: Randomised clinical trial;    Preterm;    Near-infrared spectroscopy;    Protocol;    Follow-up;    Neurodevelopment;    Brain injury;   

DOI  :  10.1186/s13063-023-07653-x

 received in 2023-06-04, accepted in 2023-09-14,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundIn the SafeBoosC-III trial, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth did not reduce the incidence of death or severe brain injury in extremely preterm infants at 36 weeks’ postmenstrual age, as compared with usual care. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. The objective of the SafeBoosC-III follow-up study is to assess mortality, neurodevelopmental disability, or any harm in trial participants at 2 years of corrected age. One important challenge is the lack of funding for local costs for a trial-specific assessment.MethodsOf the 1601 infants randomised in the SafeBoosC-III trial, 1276 infants were alive at 36 weeks’ postmenstrual age and will potentially be available for the 2-year follow-up. Inclusion criteria will be enrollment in a neonatal intensive care unit taking part in the follow-up study and parental consent if required by local regulations. We aim to collect data from routine follow-up programmes between the ages of 18 and 30 months of corrected age. If no routine follow-up has been conducted, we will collect informal assessments from other health care records from the age of at least 12 months. A local co-investigator blinded to group allocation will classify outcomes based on these records. We will supplement this with parental questionnaires including the Parent Report of Children’s Abilities—Revised. There will be two co-primary outcomes: the composite of death or moderate or severe neurodevelopmental disability and mean Bayley-III/IV cognitive score. We will use a 3-tier model for prioritisation, based on the quality of data. This approach has been chosen to minimise loss to follow-up assuming that little data is better than no data at all.DiscussionFollow-up at the age of 2 years is important for intervention trials in the newborn period as only time can show real benefits and harms later in childhood. To decrease the risk of generalisation and data-driven biased conclusions, we present a detailed description of the methodology for the SafeBoosC-III follow-up study. As funding is limited, a pragmatic approach is necessary.Trial registrationClinicalTrials.gov NCT05134116. Registered on 24 November 2021.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

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Fig. 2