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

Show simple item record

dc.contributor.author Plomgaard, Anne M.
dc.contributor.author Hagmann, Cornelia
dc.contributor.author Alderliesten, Thomas
dc.contributor.author Austin, Topun
dc.contributor.author van Bel, Frank
dc.contributor.author Claris, Olivier
dc.contributor.author Dempsey, Eugene M.
dc.contributor.author Franz, Axel
dc.contributor.author Fumagalli, Monica
dc.contributor.author Gluud, Christian
dc.contributor.author Greisen, Gorm
dc.contributor.author Hyttel-Sorensen, Simon
dc.contributor.author Lemmers, Petra
dc.contributor.author Pellicer, Adelina
dc.contributor.author Pichler, Gerhard
dc.contributor.author Benders, Manon
dc.date.accessioned 2017-08-31T15:41:59Z
dc.date.available 2017-08-31T15:41:59Z
dc.date.issued 2016-01-13
dc.identifier.citation Plomgaard, 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.2015.239 en
dc.identifier.volume 79 en
dc.identifier.issued 3 en
dc.identifier.startpage 466 en
dc.identifier.endpage 72 en
dc.identifier.issn 0031-3998
dc.identifier.uri http://hdl.handle.net/10468/4599
dc.identifier.doi 10.1038/pr.2015.239
dc.description.abstract BACKGROUND: 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.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 Nature Publishing Group en
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.uri http://creativecommons.org/licenses/by-nc-nd/4.0/ en
dc.subject Birth weight en
dc.subject Brain Injuries en
dc.subject Cerebral Hemorrhage en
dc.subject Cerebrovascular circulation en
dc.subject Feasibility Studies en
dc.subject Gestational age en
dc.subject Hemorrhage en
dc.subject Humans en
dc.subject Hypoxia en
dc.subject Infant, newborn en
dc.subject Infant, premature, en
dc.subject Diseases en
dc.subject International cooperation en
dc.subject Magnetic resonance imaging en
dc.subject Observer variation en
dc.subject Oxygen en
dc.subject Perfusion en
dc.subject Skull en
dc.subject Ultrasonography en
dc.title Brain injury in the international multicenter randomized SafeBoosC phase II feasibility trial: cranial ultrasound and magnetic resonance imaging assessments 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 2017-08-31T15:37:32Z
dc.description.version Published Version en
dc.internal.rssid 395506631
dc.contributor.funder Strategiske Forskningsråd en
dc.description.status Peer reviewed en
dc.identifier.journaltitle Pediatric Research en
dc.internal.copyrightchecked No !!CORA!! en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress g.dempsey@ucc.ie en


Files in this item

This item appears in the following Collection(s)

Show simple item record

© 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/ Except where otherwise noted, this item's license is described as © 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/
This website uses cookies. By using this website, you consent to the use of cookies in accordance with the UCC Privacy and Cookies Statement. For more information about cookies and how you can disable them, visit our Privacy and Cookies statement