A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial
Hyttel-Sorensen, Simon × Austin, Topun van Bel, Frank Benders, Manon Claris, Olivier Dempsey, Eugene Fumagalli, Monica Greisen, Gorm Grevstad, Berit Hagmann, Cornelia Hellström-Westas, Lena Lemmers, Petra Lindschou, Jane Naulaers, Gunnar van Oeveren, Wim Pellicer, Adelina Pichler, Gerhard Roll, Claudia Skoog, Maria Winkel, Per Wolf, Martin Gluud, Christian #
Trials vol:14 pages:120-125
Every year in Europe about 25,000 infants are born extremely preterm. These infants have a 20% mortality rate, and 25% of survivors have severe long-term cerebral impairment. Preventative measures are key to reduce mortality and morbidity in an extremely preterm population. The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy (NIRS) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO2.