Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments

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dc.contributor.authorPlomgaard, Anne M.
dc.contributor.authorHagmann, Cornelia
dc.contributor.authorAlderliesten, Thomas
dc.contributor.authorAustin, Topun
dc.contributor.authorvan Bel, Frank
dc.contributor.authorClaris, Olivier
dc.contributor.authorDempsey, Eugene M.
dc.contributor.authorFranz, Axel
dc.contributor.authorFumagalli, Monica
dc.contributor.authorGluud, Christian
dc.contributor.authorGreisen, Gorm
dc.contributor.authorHyttel-Sorensen, Simon
dc.contributor.authorLemmers, Petra
dc.contributor.authorPellicer, Adelina
dc.contributor.authorPichler, Gerhard
dc.contributor.authorBenders, Manon
dc.contributor.funderStrategiske Forskningsråden
dc.date.accessioned2017-08-31T15:41:59Z
dc.date.available2017-08-31T15:41:59Z
dc.date.issued2016-01-13
dc.date.updated2017-08-31T15:37:32Z
dc.description.abstractBACKGROUND: Abnormal cerebral perfusion during the first days of life in preterm infants is associated with higher grades of intraventricular hemorrhages and lower developmental score. In SafeBoosC II, we obtained a significant reduction of cerebral hypoxia by monitoring cerebral oxygenation in combination with a treatment guideline. Here, we describe (i) difference in brain injury between groups, (ii) feasibility of serial cranial ultrasound (cUS) and magnetic resonance imaging (MRI), (iii) local and central cUS assessment. METHODS: Hundred and sixty-six extremely preterm infants were included. cUS was scheduled for day 1, 4, 7, 14, and 35 and at term-equivalent age (TEA). cUS was assessed locally (unblinded) and centrally (blinded). MRI at TEA was assessed centrally (blinded). Brain injury classification: no, mild/moderate, or severe. RESULTS: Severe brain injury did not differ significantly between groups: cUS (experimental 10/80, control 18/77, P = 0.32) and MRI (5/46 vs. 3/38, P = 0.72). Kappa values for local and central readers were moderate-to-good for severe and poor-to-moderate for mild/moderate injuries. At TEA, cUS and MRI were assessed in 72 and 64%, respectively. CONCLUSION: There was no difference in severe brain injury between groups. Acquiring cUS and MRI according the standard operating procedures must be improved for future trials. Whether monitoring cerebral oxygenation during the first 72 h of life prevents brain injury should be evaluated in larger multicenter trials.en
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.citationPlomgaard, A. M., Hagmann, C., Alderliesten, T., Austin, T., van Bel, F., Claris, O., Dempsey, E., Franz, A., Fumagalli, M., Gluud, C., Greisen, G., Hyttel-Sorensen, S., Lemmers, P., Pellicer, A., Pichler, G. and Benders, M. (2016) 'Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments', Pediatr Res, 79(3), pp. 466-472. doi:10.1038/pr.2015.239en
dc.identifier.doi10.1038/pr.2015.239
dc.identifier.endpage72en
dc.identifier.issn0031-3998
dc.identifier.issued3en
dc.identifier.journaltitlePediatric Researchen
dc.identifier.startpage466en
dc.identifier.urihttps://hdl.handle.net/10468/4599
dc.identifier.volume79en
dc.language.isoenen
dc.publisherNature Publishing Groupen
dc.rights© 2016 The Authors. Published by Nature Publishing Group. This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.subjectBirth weighten
dc.subjectBrain Injuriesen
dc.subjectCerebral Hemorrhageen
dc.subjectCerebrovascular circulationen
dc.subjectFeasibility Studiesen
dc.subjectGestational ageen
dc.subjectHemorrhageen
dc.subjectHumansen
dc.subjectHypoxiaen
dc.subjectInfant, newbornen
dc.subjectInfant, premature,en
dc.subjectDiseasesen
dc.subjectInternational cooperationen
dc.subjectMagnetic resonance imagingen
dc.subjectObserver variationen
dc.subjectOxygenen
dc.subjectPerfusionen
dc.subjectSkullen
dc.subjectUltrasonographyen
dc.titleBrain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessmentsen
dc.typeArticle (peer-reviewed)en
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