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

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dc.contributor.authorHansen, Mathias Luhr
dc.contributor.authorPellicer, Adelina
dc.contributor.authorGluud, Christian
dc.contributor.authorDempsey, Eugene M.
dc.contributor.authorMintzer, Jonathan
dc.contributor.authorHyttel-Sorensen, Simon
dc.contributor.authorHeuchan, Anne Marie
dc.contributor.authorHagmann, Cornelia
dc.contributor.authorDimitriou, Gabriel
dc.contributor.authorPichler, Gerhard
dc.contributor.authorNaulaers, Gunnar
dc.contributor.authorCheng, GQ
dc.contributor.authorVilan, Ana
dc.contributor.authorTkaczyk, Jakub
dc.contributor.authorKreutzer, Karen B.
dc.contributor.authorFumagalli, Monica
dc.contributor.authorClaris, Olivier
dc.contributor.authorFredly, Siv
dc.contributor.authorSzczapa, Tomasz
dc.contributor.authorLange, Theis
dc.contributor.authorJakobsen, Janus Christian
dc.contributor.authorGreisen, Gorm
dc.contributor.funderElsass Fondenen
dc.contributor.funderSvend Andersen Fondenen
dc.contributor.funderAage og Johanne Louis-Hansens Fonden
dc.date.accessioned2022-05-30T15:22:13Z
dc.date.available2022-05-30T15:22:13Z
dc.date.issued2019-12-01
dc.date.updated2022-05-23T14:08:31Z
dc.description.abstractBackground: 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)). 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.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid746en
dc.identifier.citationHansen, M. L., Pellicer, A., Gluud, C., Dempsey, E., Mintzer, J., Hyttel-Sorensen, S., Heuchan, A-M., Hagmann, C., Dimitriou, G., Pichler, G., Naulaers, G., Cheng, G., Vilan, A., Tkaczyk, J., Kreutzer, K. B., Fumagalli, M., Claris, O., Fredly, S., Szczapa, T., Lange, T., Jakobsen, J. C. and Greisen, G. (2019) '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', Trials, 20, 746 (12pp). doi: 10.1186/s13063-019-3756-yen
dc.identifier.doi10.1186/s13063-019-3756-yen
dc.identifier.endpage12en
dc.identifier.issn1745-6215
dc.identifier.journaltitleTrialsen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/13272
dc.identifier.volume20en
dc.language.isoenen
dc.publisherSpringer Natureen
dc.rights© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en
dc.subjectTime-to-eventen
dc.subjectObserver biasen
dc.subjectOutcomesen
dc.subject~Paediatrics and Child Health - Journal Articles~en
dc.titleDetailed 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 infantsen
dc.typeArticle (peer-reviewed)en
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