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 Hellstroem-Westas, Simon Hyttel-Sorensen, Petra Lemmers, Gunnar Naulaers, Gerhard Pichler, Claudia Roll, Frank van Bel, Wim van Oeveren, Maria Skoog, Martin Wolf, Topun Austin, SafeBoosC Trial Grp

*Corresponding author for this work

    Research output: Contribution to journalArticleAcademicpeer-review

    85 Citations (Scopus)

    Abstract

    Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rSto(2)) reflects venous oxygen saturation. If cerebral metabolism is stable, rSto(2) 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 rSto(2) and a treatment guideline to correct deviations in rSto(2) outside a predefined target range. Aims: To describe the rationale for and content of this treatment guideline. Methods: Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions. Results and Conclusions: A 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. (C) 2013 S. Karger AG, Basel

    Original languageEnglish
    Pages (from-to)171-178
    Number of pages8
    JournalNeonatology
    Volume104
    Issue number3
    DOIs
    Publication statusPublished - 2013

    Keywords

    • Near-infrared spectroscopy
    • Newborn
    • Practice guideline
    • Cardiovascular agents
    • Hypotension
    • Oxygen consumption
    • Carbon dioxide
    • Hyperoxia
    • PATENT DUCTUS-ARTERIOSUS
    • BIRTH-WEIGHT INFANTS
    • LEFT-VENTRICULAR OUTPUT
    • SERVICES-TASK-FORCE
    • BLOOD-FLOW
    • PREMATURE-INFANTS
    • SURGICAL CLOSURE
    • CARDIAC-OUTPUT
    • INTENSIVE-CARE
    • INTRAVENTRICULAR HEMORRHAGE

    Cite this