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

TY - JOUR

T1 - The SafeBoosC Phase II Randomised Clinical Trial

T2 - A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants

AU - Pellicer, Adelina

AU - Greisen, Gorm

AU - Benders, Manon

AU - Claris, Olivier

AU - Dempsey, Eugene

AU - Fumagally, Monica

AU - Gluud, Christian

AU - Hagmann, Cornelia

AU - Hellström-Westas, Lena

AU - Hyttel-Sorensen, Simon

AU - Lemmers, Petra

AU - Naulaers, Gunnar

AU - Pichler, Gerhard

AU - Roll, Claudia

AU - van Bel, Frank

AU - van Oeveren, Wim

AU - Skoog, Maria

AU - Wolf, Martin

AU - Austin, Topun

PY - 2013/9

Y1 - 2013/9

N2 - Near-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. 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.

AB - Near-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. 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.

U2 - 10.1159/000351346

DO - 10.1159/000351346

M3 - Journal article

SN - 1661-7800

VL - 104

SP - 171

EP - 178

JO - Neonatology

JF - Neonatology

IS - 3

ER -