Journal Article

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

Gluud, Christian, Benders, Manon, van Bel, Frank, Pellicer, Adelina, Lemmers, Petra, Hagmann, Cornelia, Greisen, Gorm, Austin, Topun, Hyttel-Sorensen, Simon, Dempsey, Eugene, van Oeveren, Wim, Fumagally, Monica, Wolf, Martin, Hellström-Westas, Lena, Pichler, Gerhard, Roll, Claudia, Skoog, Maria, Claris, Olivier, Naulaers, Gunnar

2013

Overview

Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rSt O 2 ) reflects venous oxygen saturation. If cerebral metabolism is stable, rSt O 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 rSt O 2 and a treatment guideline to correct deviations in rSt O 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.

• Publisher: S. Karger AG
• Subject: Algorithms / Brain - physiology / Carbon dioxide / Cardiovascular agents / Clinical Trials, Phase II as Topic - methods / Clinical Trials, Phase II as Topic - standards / Humans / Hyperoxia / Hypotension / Infant, Extremely Premature - physiology / Infant, Newborn / Near-infrared spectroscopy / Newborn / Oximetry - methods / Oxygen - administration & dosage / Oxygen - physiology / Oxygen consumption / Practice guideline / Practice Guidelines as Topic / Randomized Controlled Trials as Topic - methods / Randomized Controlled Trials as Topic - standards / Research Briefings / Spectroscopy, Near-Infrared - standards