• Danish medical journal · Jan 2013

    Clinical Trial

    Clinical use of cerebral oximetry in extremely preterm infants is feasible.

    • Simon Hyttel-Sørensen, Topun Austin, Frank van Bel, Manon Benders, Olivier Claris, Eugene M Dempsey, Monica Fumagalli, Christian Gluud, Cornelia Hagmann, Lena Hellström-Westas, Petra Lemmers, Gunnar Naulaers, Wim van Oeveren, Adelina Pellicer, Gerhard Pichler, Claudia Roll, Lina Saem Støy, Martin Wolf, and Gorm Greisen.
    • Department of Neonatology, 5021, Rigshospitalet, 2100 Copenhagen, Denmark. simonhyttelsrensen@me.com
    • Dan Med J. 2013 Jan 1;60(1):A4533.

    IntroductionThe research programme Safeguarding the Brains of our smallest Children (SafeBoosC) aims to test the benefits and harms of cerebral near-infrared spectroscopy (NIRS) oximetry in infants born before 28 weeks of gestation. In a phase II trial, infants will be randomised to visible cerebral NIRS oximetry with pre-specified treatment guidelines compared to standard care with blinded NIRS-monitoring. The primary outcome is duration multiplied with the extent outside the normal range of regional tissue oxygen saturation of haemoglobin (rStO2) of 55 to 85% in percentage hours (burden). This study was a pilot of the Visible -Oximetry Group.Material And MethodsThis was an observational study including ten infants.ResultsThe median gestational age was 26 weeks+three days, and the median start-up time was 133 minutes after delivery. The median recording time was 69.7 hours, mean rStO2 was 64.2±4.5%, median burden of hyper- and hypoxia was 30.3% hours (range 2.8-112.3). Clinical staff responded to an out of range value 29 times--only once to values above 85%. In comparison, there were 83 periods of more than ten minutes with an rStO2 below 55% and four episodes with an rStO2 above 85%. These periods accounted for 72% of the total hypoxia burden. A total of 18 of the 29 interventions were adjustments of FiO2 which in 13 of the 18 times resulted in an out-of-range SpO2. Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment.ConclusionThe intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required.FundingThe Elsass Foundation funded the present study.Trial RegistrationClinicaltrials.gov: NCT01530360.

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