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Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants

ML. Hansen, A. Pellicer, C. Gluud, E. Dempsey, J. Mintzer, S. Hyttel-Sorensen, AM. Heuchan, C. Hagmann, G. Dimitriou, G. Pichler, G. Naulaers, G. Cheng, A. Vilan, J. Tkaczyk, KB. Kreutzer, M. Fumagalli, O. Claris, S. Fredly, T. Szczapa, T. Lange,...

. 2019 ; 20 (1) : 746. [pub] 20191219

Language English Country Great Britain

Document type Letter

Persistent link   https://www.medvik.cz/link/bmc20025394

Grant support
18-3-0133 Elsass Foundation

BACKGROUND: Infants born extremely preterm are at high risk of dying or suffering from severe brain injuries. Treatment guided by monitoring of cerebral oxygenation may reduce the risk of death and neurologic complications. The SafeBoosC III trial evaluates the effects of treatment guided by cerebral oxygenation monitoring versus treatment as usual. This article describes the detailed statistical analysis plan for the main publication, with the aim to prevent outcome reporting bias and data-driven analyses. METHODS/DESIGN: The SafeBoosC III trial is an investigator-initiated, randomised, multinational, pragmatic phase III trial with a parallel group structure, designed to investigate the benefits and harms of treatment based on cerebral near-infrared spectroscopy monitoring compared with treatment as usual. Randomisation will be 1:1 stratified for neonatal intensive care unit and gestational age (lower gestational age (< 26 weeks) compared to higher gestational age (≥ 26 weeks)). The primary outcome is a composite of death or severe brain injury at 36 weeks postmenstrual age. Primary analysis will be made on the intention-to-treat population for all outcomes, using mixed-model logistic regression adjusting for stratification variables. In the primary analysis, the twin intra-class correlation coefficient will not be considered. However, we will perform sensitivity analyses to address this. Our simulation study suggests that the inclusion of multiple births is unlikely to significantly affect our assessment of intervention effects, and therefore we have chosen the analysis where the twin intra-class correlation coefficient will not be considered as the primary analysis. DISCUSSION: In line with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines, we have developed and published this statistical analysis plan for the SafeBoosC III trial, prior to any data analysis. TRIAL REGISTRATION: ClinicalTrials.org, NCT03770741. Registered on 10 December 2018.

Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet Copenhagen University Hospital Blegdamsvej 9 2100 Copenhagen Denmark

Copenhagen Trial Unit Centre for Clinical Intervention Research Rigshospitalet Copenhagen University Hospital Blegdamsvej 9 2100 Copenhagen Denmark Department of Cardiology Holbæk Hospital Smedelundsgade 60 4300 Holbæk Denmark Department of Regional Health Research The Faculty of Health Sciences University of Southern Denmark Odense Denmark

Department of Neonatology Centrohospitalar Universitário de São João Alameda Prof Hernâni Monteiro 4200 319 Porto Portugal

Department of Neonatology Children's Hospital of Fudan University 399 Wanyuan Rd Minhang Qu Shanghai Shi China

Department of Neonatology Children's University Hospital of Zürich Steinweisstrasse 75 8037 Zurich Switzerland

Department of Neonatology Hospices Civil De Lyon 3 Quai des Célestins 69002 Lyon France

Department of Neonatology La Paz University Hospital Paseo De La Castellana 261 28046 Madrid Spain

Department of Neonatology Oslo University Hospital Kirkeveien 166 0450 Oslo Norway

Department of Neonatology Poznan University of Medical Sciences Polna 33 60 535 Poznań Poland

Department of Neonatology Rigshospitalet Copenhagen University Hospital Blegdamsvej 9 2100 Copenhagen Denmark

Department of Neonatology Royal Hospital for Children 1345 Govan Rd Glasgow G51 4TF UK

Department of Neonatology University Children's Hospital Tuebingen Hoppe Seyler Straße 1 72076 Tuebingen Germany

Department of Neonatology University Hospital Leuven Herestraat 49 Leuven Belgium

Department of Neonatology University Hospital Motol 5 Uvalu 84 150 06 Prague 5 Czech Republic

Department of Pediatrics Medical University of Graz Auenbruggerplatz 30 Graz Austria

Division of Neonatal Perinatal Medicine Mountainside Medical Center Montclair NJ USA

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan Via della Commenda 12 20122 Milan Italy Department of Clinical Sciences and Community Health University of Milan Milan Italy

Infant Centre and Department of Paediatrics and Child Health University College Cork College Road Cork Ireland

NICU Department of Pediatrics University General Hospital of Patras 265 04 Patras Greece

Section of Biostatistics Department of Publich Health Copenhagen University Øster Farimagsgade 5 Copenhagen K Denmark Center for Statistical Science Peking University Beijing China

References provided by Crossref.org

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