Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial

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dc.contributor.author Pellicer, Adelina
dc.contributor.author Alderliesten, Thomas
dc.contributor.author Austin, Topun
dc.contributor.author van Bel, Frank
dc.contributor.author Benders, Manon
dc.contributor.author Hyttel-Sorensen, Simon
dc.contributor.author Claris, Olivier
dc.contributor.author Dempsey, Eugene M.
dc.contributor.author Franz, Axel
dc.contributor.author Gluud, Christian
dc.contributor.author Grevstad, Berit
dc.contributor.author Hagmann, Cornelia
dc.contributor.author Lemmers, Petra
dc.contributor.author van Oeveren, Wim
dc.contributor.author Pichler, Gerhard
dc.contributor.author Plomgaard, Anne Mette
dc.contributor.author Riera, Joan
dc.contributor.author Sanchez, Laura
dc.contributor.author Winkel, Per
dc.contributor.author Wolf, Martin
dc.contributor.author Greisen, Gorm
dc.date.accessioned 2017-09-01T13:35:32Z
dc.date.available 2017-09-01T13:35:32Z
dc.date.issued 2015-01-05
dc.identifier.citation Hyttel-Sorensen, S., Pellicer, A., Alderliesten, T., Austin, T., van Bel, F., Benders, M., Claris, O., Dempsey, E., Franz, A. R., Fumagalli, M., Gluud, C., Grevstad, B., Hagmann, C., Lemmers, P., van Oeveren, W., Pichler, G., Plomgaard, A. M., Riera, J., Sanchez, L., Winkel, P., Wolf, M. and Greisen, G. (2015) 'Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial', BMJ : British Medical Journal, 350 (11pp.) doi: 10.1136/bmj.g7635 en
dc.identifier.volume 350 en
dc.identifier.startpage 1 en
dc.identifier.endpage 11 en
dc.identifier.issn 1756-1833
dc.identifier.uri http://hdl.handle.net/10468/4606
dc.identifier.doi 10.1136/bmj.g7635
dc.description.abstract Objective To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry. Design Phase II randomised, single blinded, parallel clinical trial. Setting Eight tertiary neonatal intensive care units in eight European countries. Participants 166 extremely preterm infants born before 28 weeks of gestation: 86 were randomised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring. The only exclusion criterion was a decision not to provide life support. Interventions Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life (experimental) compared with blinded NIRS oxygenation monitoring with standard care (control).Main outcome measures The primary outcome measure was the time spent outside the target range of 55-85% for cerebral oxygenation multiplied by the mean absolute deviation, expressed in %hours (burden of hypoxia and hyperoxia). One hour with an oxygenation of 50% gives 5%hours of hypoxia. Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography. Randomisation Allocation sequence 1:1 with block sizes 4 and 6 in random order concealed for the investigators. The allocation was stratified for gestational age (<26 weeks or >26 weeks).Blinding Cerebral oxygenation measurements were blinded in the control group. All outcome assessors were blinded to group allocation. Results The 86 infants randomised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours (interquartile range 9.2-79.5%hours) compared with 81.3 (38.5-181.3) %hours in the control group, a reduction of 58% (95% confidence interval 35% to 73%, P&lt;0.001). In the experimental group the median burden of hypoxia was 16.6 (interquartile range 5.4-68.1) %hours, compared with 53.6 (17.4-171.3) %hours in the control group (P=0.0012). The median burden of hyperoxia was similar between the groups: 1.2 (interquartile range 0.3-9.6) %hours in the experimental group compared with 1.1 (0.1-23.4) %hours in the control group (P=0.98). We found no statistically significant differences between the two groups at term corrected age. No severe adverse reactions were associated with the device. Conclusions Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring.Trial registration ClinicalTrial.gov NCT01590316 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 BMJ Publishing Group en
dc.rights © 2015 The Authors. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. en
dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/ en
dc.subject Anoxia en
dc.subject Brain en
dc.subject Cerebrovascular circulation en
dc.subject Clinical Protocols en
dc.subject Infant, extremely premature en
dc.subject Newborn en
dc.subject Intensive care units en
dc.subject Neonatal intensive care en
dc.subject Near-Infrared spectroscopy en
dc.title Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial 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 2017-09-01T12:04:08Z
dc.description.version Published Version en
dc.internal.rssid 286548394
dc.contributor.funder Strategiske Forskningsråd en
dc.description.status Peer reviewed en
dc.identifier.journaltitle BMJ British Medical Journal en
dc.internal.copyrightchecked No !!CORA!! en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress g.dempsey@ucc.ie en


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© 2015 The Authors. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. Except where otherwise noted, this item's license is described as © 2015 The Authors. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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