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.authorvan Oeveren, Wim
dc.contributor.authorPlomgaard, Anne M.
dc.contributor.authorPetersen, Tue H.
dc.contributor.authorAlderliesten, Thomas
dc.contributor.authorAustin, Topun
dc.contributor.authorvan Bel, Frank
dc.contributor.authorBenders, Manon
dc.contributor.authorClaris, Olivier
dc.contributor.authorDempsey, Eugene M.
dc.contributor.authorFranz, Axel
dc.contributor.authorFumagalli, Monica
dc.contributor.authorGluud, Christian
dc.contributor.authorHagmann, Cornelia
dc.contributor.authorHyttel-Sorensen, Simon
dc.contributor.authorLemmers, Petra
dc.contributor.authorPellicer, Adelina
dc.contributor.authorPichler, Gerhard
dc.contributor.authorWinkel, Per
dc.contributor.authorGreisen, Gorm
dc.contributor.funderStrategiske Forskningsråden
dc.date.accessioned2017-08-31T15:15:42Z
dc.date.available2017-08-31T15:15:42Z
dc.date.issued2016-01-20
dc.date.updated2017-08-31T15:08:31Z
dc.description.abstractBACKGROUND: 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.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., 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.2015.266en
dc.identifier.doi10.1038/pr.2015.266
dc.identifier.endpage535en
dc.identifier.issn0031-3998
dc.identifier.issued4en
dc.identifier.journaltitlePediatric Researchen
dc.identifier.startpage528en
dc.identifier.urihttps://hdl.handle.net/10468/4598
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.subjectBiomarkersen
dc.subjectMetabolismen
dc.subjectBrain Injuriesen
dc.subjectElectroencephalographyen
dc.subjectHumansen
dc.subjectHypoxiaen
dc.subjectInfant, newbornen
dc.subjectSpectroscopy, near-infrareden
dc.titleThe SafeBoosC II randomized trial: treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injuryen
dc.typeArticle (peer-reviewed)en
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