• Neonatology · Jan 2013

    Randomized Controlled Trial

    The SafeBoosC phase II randomised clinical trial: a treatment guideline for targeted near-infrared-derived cerebral tissue oxygenation versus standard treatment in extremely preterm infants.

    • Adelina Pellicer, Gorm Greisen, Manon Benders, Olivier Claris, Eugene Dempsey, Monica Fumagalli, Christian Gluud, Cornelia Hagmann, Lena Hellström-Westas, Simon Hyttel-Sorensen, Petra Lemmers, Gunnar Naulaers, Gerhard Pichler, Claudia Roll, Frank van Bel, Wim van Oeveren, Maria Skoog, Martin Wolf, and Topun Austin.
    • Department of Neonatology, La Paz University Hospital, Madrid, Spain.
    • Neonatology. 2013 Jan 1;104(3):171-8.

    UnlabelledNear-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rStO2) reflects venous oxygen saturation. If cerebral metabolism is stable, rStO2 can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rStO2 and a treatment guideline to correct deviations in rStO2 outside a predefined target range.AimsTo describe the rationale for and content of this treatment guideline.MethodsReview of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions.Results And ConclusionsA clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated. The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II randomised clinical trial. The evidence grades were relatively low and the guideline cannot be recommended outside a research setting.© 2013 S. Karger AG, Basel.

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