Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial

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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.authorErgenekon, Ebru
dc.contributor.authorDimitriou, Gabriel
dc.contributor.authorPichler, Gerhard
dc.contributor.authorNaulaers, Gunnar
dc.contributor.authorCheng, Guoqiang
dc.contributor.authorGuimaraes, Hercilia
dc.contributor.authorTkaczyk, Jakub
dc.contributor.authorKreutzer, Karen B.
dc.contributor.authorFumagalli, Monica
dc.contributor.authorClaris, Olivier
dc.contributor.authorLemmers, Petra
dc.contributor.authorFredly, Siv
dc.contributor.authorSzczapa, Tomasz
dc.contributor.authorAustin, Topun
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.accessioned2022-06-01T09:37:03Z
dc.date.available2022-06-01T09:37:03Z
dc.date.issued2019-12
dc.date.updated2022-06-01T08:51:18Z
dc.description.abstractBackground: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.Methods/design: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants.Discussion: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid811en
dc.identifier.citationHansen, M. L., Pellicer, A., Gluud, C., Dempsey, E. M., Mintzer, J., Hyttel-Sorensen, S., Heuchan, A-M., Hagmann, C., Ergenekon, E., Dimitriou, G., Pichler, G., Naulaers, G., Cheng, G., Guimaraes, H., Tkaczyk, J., Kreutzer, K. B., Fumagalli, M., Claris, O., Lemmers, P., Fredly, S., Szczapa, T., Austin, T., Jakobsen, J. C. and Greisen, G. (2019) 'Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial', Trials, 20, 811 (11pp). doi: 10.1186/s13063-019-3955-6en
dc.identifier.doi10.1186/s13063-019-3955-6en
dc.identifier.endpage11en
dc.identifier.issn1745-6215
dc.identifier.journaltitleTrialsen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/13278
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.subjectObserver biasen
dc.subjectOutcomesen
dc.subjectInjuryen
dc.subjectInterventionsen
dc.subjectStandarden
dc.titleCerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trialen
dc.typeArticle (peer-reviewed)en
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