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

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dc.contributor.authorPellicer, Adelina
dc.contributor.authorAlderliesten, Thomas
dc.contributor.authorAustin, Topun
dc.contributor.authorvan Bel, Frank
dc.contributor.authorBenders, Manon
dc.contributor.authorHyttel-Sorensen, Simon
dc.contributor.authorClaris, Olivier
dc.contributor.authorDempsey, Eugene M.
dc.contributor.authorFranz, Axel
dc.contributor.authorGluud, Christian
dc.contributor.authorGrevstad, Berit
dc.contributor.authorHagmann, Cornelia
dc.contributor.authorLemmers, Petra
dc.contributor.authorvan Oeveren, Wim
dc.contributor.authorPichler, Gerhard
dc.contributor.authorPlomgaard, Anne Mette
dc.contributor.authorRiera, Joan
dc.contributor.authorSanchez, Laura
dc.contributor.authorWinkel, Per
dc.contributor.authorWolf, Martin
dc.contributor.authorGreisen, Gorm
dc.contributor.funderStrategiske Forskningsråden
dc.date.accessioned2017-09-01T13:35:32Z
dc.date.available2017-09-01T13:35:32Z
dc.date.issued2015-01-05
dc.date.updated2017-09-01T12:04:08Z
dc.description.abstractObjective 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 NCT01590316en
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.citationHyttel-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.g7635en
dc.identifier.doi10.1136/bmj.g7635
dc.identifier.endpage11en
dc.identifier.issn1756-1833
dc.identifier.journaltitleBMJ British Medical Journalen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/4606
dc.identifier.volume350en
dc.language.isoenen
dc.publisherBMJ Publishing Groupen
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.urihttp://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectAnoxiaen
dc.subjectBrainen
dc.subjectCerebrovascular circulationen
dc.subjectClinical Protocolsen
dc.subjectInfant, extremely prematureen
dc.subjectNewbornen
dc.subjectIntensive care unitsen
dc.subjectNeonatal intensive careen
dc.subjectNear-Infrared spectroscopyen
dc.titleCerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trialen
dc.typeArticle (peer-reviewed)en
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