The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

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dc.contributor.author van Oeveren, Wim
dc.contributor.author Plomgaard, Anne M.
dc.contributor.author Petersen, Tue H.
dc.contributor.author Alderliesten, Thomas
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 Franz, Axel
dc.contributor.author Fumagalli, Monica
dc.contributor.author Gluud, Christian
dc.contributor.author Hagmann, Cornelia
dc.contributor.author Hyttel-Sorensen, Simon
dc.contributor.author Lemmers, Petra
dc.contributor.author Pellicer, Adelina
dc.contributor.author Pichler, Gerhard
dc.contributor.author Winkel, Per
dc.contributor.author Greisen, Gorm
dc.date.accessioned 2017-08-31T15:15:42Z
dc.date.available 2017-08-31T15:15:42Z
dc.date.issued 2016-01-20
dc.identifier.citation Plomgaard, A. M., van Oeveren, W., Petersen, T. H., Alderliesten, T., Austin, T., van Bel, F., Benders, M., Claris, O., Dempsey, E., Franz, A., Fumagalli, M., Gluud, C., Hagmann, C., Hyttel-Sorensen, S., Lemmers, P., Pellicer, A., Pichler, G., Winkel, P. and Greisen, G. (2016) 'The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury', Pediatr Res, 79(4), pp. 528-535. doi: 10.1038/pr.2015.266 en
dc.identifier.volume 79 en
dc.identifier.issued 4 en
dc.identifier.startpage 528 en
dc.identifier.endpage 535 en
dc.identifier.issn 0031-3998
dc.identifier.uri http://hdl.handle.net/10468/4598
dc.identifier.doi 10.1038/pr.2015.266
dc.description.abstract BACKGROUND: The SafeBoosC phase II multicentre randomized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline vs. no NIRS data and treatment as usual in the control group during the first 72 h of life. The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group. We now report the blindly assessed and analyzed treatment effects on electroencephalographic (EEG) outcomes (burst rate and spectral edge frequency 95% (SEF95)) and blood biomarkers of brain injury (S100beta, brain fatty acid-binding protein, and neuroketal). METHODS: One hundred and sixty-six extremely preterm infants were randomized to either experimental or control group. EEG was recorded at 64 h of age and blood samples were collected at 6 and 64 h of age. RESULTS: One hundred and thirty-three EEGs were evaluated. The two groups did not differ regarding burst rates (experimental 7.2 vs. control 7.7 burst/min) or SEF95 (experimental 18.1 vs. control 18.0 Hz). The two groups did not differ regarding blood S100beta, brain fatty acid-binding protein, and neuroketal concentrations at 6 and 64 h (n = 123 participants). CONCLUSION: Treatment guided by NIRS reduced the cerebral burden of hypoxia without affecting EEG or the selected blood biomarkers. 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 Biomarkers en
dc.subject Metabolism en
dc.subject Brain Injuries en
dc.subject Electroencephalography en
dc.subject Humans en
dc.subject Hypoxia en
dc.subject Infant, newborn en
dc.subject Spectroscopy, near-infrared en
dc.title The SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury 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 2017-08-31T15:08:31Z
dc.description.version Published Version en
dc.internal.rssid 395506633
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


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© 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/
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