A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial

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dc.contributor.author Hyttel-Sorensen, Simon
dc.contributor.author Austin, Topun
dc.contributor.author van Bel, Frank
dc.contributor.author Benders, Manon
dc.contributor.author Claris, Olivier
dc.contributor.author Dempsey, Eugene M.
dc.contributor.author Fumagalli, Monica
dc.contributor.author Greisen, Gorm
dc.contributor.author Grevstad, Berit
dc.contributor.author Hagmann, Cornelia
dc.contributor.author Hellström-Westas, Lena
dc.contributor.author Lemmers, Petra
dc.contributor.author Lindschou, Jane
dc.contributor.author Naulaers, Gunnar
dc.contributor.author van Oeveren, Wim
dc.contributor.author Pellicer, Adelina
dc.contributor.author Pichler, Gerhard
dc.contributor.author Roll, Claudia
dc.contributor.author Skoog, Maria
dc.contributor.author Winkel, Per
dc.contributor.author Wolf, Martin
dc.contributor.author Gluud, Christian
dc.date.accessioned 2017-09-01T14:20:01Z
dc.date.available 2017-09-01T14:20:01Z
dc.date.issued 2013-05-01
dc.identifier.citation Hyttel-Sorensen, S., Austin, T., van Bel, F., Benders, M., Claris, O., Dempsey, E., Fumagalli, M., Greisen, G., Grevstad, B., Hagmann, C., Hellström-Westas, L., Lemmers, P., Lindschou, J., Naulaers, G., van Oeveren, W., Pellicer, A., Pichler, G., Roll, C., Skoog, M., Winkel, P., Wolf, M. and Gluud, C. (2013) 'A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial', Trials, 14(1), 120 (8 pp.) doi: 10.1186/1468-6708-14-120 en
dc.identifier.volume 14 en
dc.identifier.startpage 120-1 en
dc.identifier.endpage 120-8 en
dc.identifier.issn 1745-6215
dc.identifier.uri http://hdl.handle.net/10468/4607
dc.identifier.doi 10.1186/1468-6708-14-120
dc.description.abstract Background: Every year in Europe about 25,000 infants are born extremely preterm. These infants have a 20% mortality rate, and 25% of survivors have severe long-term cerebral impairment. Preventative measures are key to reduce mortality and morbidity in an extremely preterm population. The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy (NIRS) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO2. Methods/Design: SafeBoosC is a randomized, blinded, multinational, phase II clinical trial. The inclusion criteria are: neonates born more than 12 weeks preterm; decision to conduct full life support; parental informed consent; and possibility to place the cerebral NIRS oximeter within 3 hours after birth. The infants will be randomized into one of two groups. Both groups will have a cerebral oximeter monitoring device placed within three hours of birth. In the experimental group, the cerebral oxygenation reading will supplement the standard treatment using a predefined treatment guideline. In the control group, the cerebral oxygenation reading will not be visible and the infant will be treated according to the local standards. The primary outcome is the multiplication of the duration and magnitude of rStO2 values outside the target ranges of 55% to 85%, that is, the ‘burden of hypoxia and hyperoxia’ expressed in ‘%hours’. To detect a 50% difference between the experimental and control group in %hours, 166 infants in total must be randomized. Secondary outcomes are mortality at term date, cerebral ultrasound score, and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected age, magnetic resonance imaging at term, blood biomarkers at 6 and 64 hours after birth, and adverse events. Discussion: Cerebral oximetry guided interventions have the potential to improve neurodevelopmental outcome in extremely preterm infants. It is a logical first step to test if it is possible to reduce the burden of hypoxia and hyperoxia. Trial registration: ClinicalTrial.gov, NCT01590316 en
dc.description.sponsorship Strategiske Forskningsråd (Danish Council for Strategic Research grant DKK 11,100,105) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher BioMed Central en
dc.rights © Hyttel-Sorensen et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. en
dc.rights.uri http://creativecommons.org/licenses/by/2.0 en
dc.subject Randomized clinical trial en
dc.subject Preterm en
dc.subject Near infrared spectroscopy en
dc.subject Protocol en
dc.title A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Eugene Dempsey, Paediatrics & Child Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: g.dempsey@ucc.ie en
dc.internal.availability Full text available en
dc.date.updated 2017-09-01T14:12:34Z
dc.description.version Published Version en
dc.internal.rssid 348782413
dc.internal.wokid WOS:000319189600001
dc.contributor.funder Strategiske Forskningsråd en
dc.description.status Peer reviewed en
dc.identifier.journaltitle Trials en
dc.internal.copyrightchecked No !!CORA!! en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress g.dempsey@ucc.ie en


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© Hyttel-Sorensen et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Except where otherwise noted, this item's license is described as © Hyttel-Sorensen et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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