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

dc.contributor.authorHyttel-Sorensen, Simon
dc.contributor.authorAustin, Topun
dc.contributor.authorvan Bel, Frank
dc.contributor.authorBenders, Manon
dc.contributor.authorClaris, Olivier
dc.contributor.authorDempsey, Eugene M.
dc.contributor.authorFumagalli, Monica
dc.contributor.authorGreisen, Gorm
dc.contributor.authorGrevstad, Berit
dc.contributor.authorHagmann, Cornelia
dc.contributor.authorHellström-Westas, Lena
dc.contributor.authorLemmers, Petra
dc.contributor.authorLindschou, Jane
dc.contributor.authorNaulaers, Gunnar
dc.contributor.authorvan Oeveren, Wim
dc.contributor.authorPellicer, Adelina
dc.contributor.authorPichler, Gerhard
dc.contributor.authorRoll, Claudia
dc.contributor.authorSkoog, Maria
dc.contributor.authorWinkel, Per
dc.contributor.authorWolf, Martin
dc.contributor.authorGluud, Christian
dc.contributor.funderStrategiske Forskningsråden
dc.date.accessioned2017-09-01T14:20:01Z
dc.date.available2017-09-01T14:20:01Z
dc.date.issued2013-05-01
dc.date.updated2017-09-01T14:12:34Z
dc.description.abstractBackground: 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, NCT01590316en
dc.description.sponsorshipStrategiske Forskningsråd (Danish Council for Strategic Research grant DKK 11,100,105)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationHyttel-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: 10.1186/1468-6708-14-120en
dc.identifier.doi10.1186/1468-6708-14-120
dc.identifier.endpage120-8en
dc.identifier.issn1745-6215
dc.identifier.journaltitleTrialsen
dc.identifier.startpage120-1en
dc.identifier.urihttps://hdl.handle.net/10468/4607
dc.identifier.volume14en
dc.language.isoenen
dc.publisherBioMed Centralen
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.urihttp://creativecommons.org/licenses/by/2.0en
dc.subjectRandomized clinical trialen
dc.subjectPretermen
dc.subjectNear infrared spectroscopyen
dc.subjectProtocolen
dc.titleA 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 trialen
dc.typeArticle (peer-reviewed)en
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