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

Simon Hyttel-Sorensen, Adelina Pellicer, Thomas Alderliesten, Topun Austin, Frank Van Bel, Manon Benders, Olivier Claris, Eugene Dempsey, Axel R. Franz, Monica Fumagalli, Christian Gluud, Berit Grevstad, Cornelia Hagmann, Petra Lemmers, Wim Van Oeveren, Gerhard Pichler, Anne Mette Plomgaard, Joan Riera, Laura Sanchez, Per WinkelMartin Wolf, Gorm Greisen

Research output: Contribution to journalArticle

108 Citations (Scopus)

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 (

Original languageEnglish
Article numberg7635
JournalBritish Medical Journal
Volume350
DOIs
Publication statusPublished - Jan 5 2015

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Extremely Premature Infants
Phase II Clinical Trials
Oximetry
Near-Infrared Spectroscopy
Randomized Controlled Trials
Outcome Assessment (Health Care)
Hyperoxia
Neonatal Intensive Care Units
Random Allocation
Brain Injuries
Gestational Age
Ultrasonography
Research Personnel
Clinical Trials
Guidelines
Pregnancy
Mortality

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Hyttel-Sorensen, S., Pellicer, A., Alderliesten, T., Austin, T., Van Bel, F., Benders, M., ... Greisen, G. (2015). Cerebral near infrared spectroscopy oximetry in extremely preterm infants: Phase II randomised clinical trial. British Medical Journal, 350, [g7635]. https://doi.org/10.1136/bmj.g7635

Cerebral near infrared spectroscopy oximetry in extremely preterm infants : Phase II randomised clinical trial. / Hyttel-Sorensen, Simon; Pellicer, Adelina; Alderliesten, Thomas; Austin, Topun; Van Bel, Frank; Benders, Manon; Claris, Olivier; Dempsey, Eugene; Franz, Axel R.; Fumagalli, Monica; Gluud, Christian; Grevstad, Berit; Hagmann, Cornelia; Lemmers, Petra; Van Oeveren, Wim; Pichler, Gerhard; Plomgaard, Anne Mette; Riera, Joan; Sanchez, Laura; Winkel, Per; Wolf, Martin; Greisen, Gorm.

In: British Medical Journal, Vol. 350, g7635, 05.01.2015.

Research output: Contribution to journalArticle

Hyttel-Sorensen, S, Pellicer, A, Alderliesten, T, Austin, T, Van Bel, F, Benders, M, Claris, O, Dempsey, E, Franz, AR, Fumagalli, M, Gluud, C, Grevstad, B, Hagmann, C, Lemmers, P, Van Oeveren, W, Pichler, G, Plomgaard, AM, Riera, J, Sanchez, L, Winkel, P, Wolf, M & Greisen, G 2015, 'Cerebral near infrared spectroscopy oximetry in extremely preterm infants: Phase II randomised clinical trial', British Medical Journal, vol. 350, g7635. https://doi.org/10.1136/bmj.g7635
Hyttel-Sorensen S, Pellicer A, Alderliesten T, Austin T, Van Bel F, Benders M et al. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: Phase II randomised clinical trial. British Medical Journal. 2015 Jan 5;350. g7635. https://doi.org/10.1136/bmj.g7635
Hyttel-Sorensen, Simon ; Pellicer, Adelina ; Alderliesten, Thomas ; Austin, Topun ; Van Bel, Frank ; Benders, Manon ; Claris, Olivier ; Dempsey, Eugene ; Franz, Axel R. ; Fumagalli, Monica ; Gluud, Christian ; Grevstad, Berit ; Hagmann, Cornelia ; Lemmers, Petra ; Van Oeveren, Wim ; Pichler, Gerhard ; Plomgaard, Anne Mette ; Riera, Joan ; Sanchez, Laura ; Winkel, Per ; Wolf, Martin ; Greisen, Gorm. / Cerebral near infrared spectroscopy oximetry in extremely preterm infants : Phase II randomised clinical trial. In: British Medical Journal. 2015 ; Vol. 350.
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