Cerebral Tissue Oxygen Saturation to Guide Oxygen Delivery

Clinical question: The brain is currently not routinely monitored in neonates during immediate transition after birth. However, impaired oxygen supply of the brain in this adaptation process might cause brain injury in preterm neonates. The primary objective of this study is, therefore, to examine, whether it is possible to improve survival without brain injury in preterm neonates <32 weeks gestation by monitoring/measurement of oxygen saturation of the brain during immediate transition after birth and treatment guidelines based on these measurements. Primary hypothesis: Continuous measurement of oxygen saturation of the brain during immediate transition after birth and defined treatment guidelines improve survival without brain injury in preterm infants. Methods: Inclusion criteria: preterm neonates <32 weeks of gestation in European countries and North America with intention to treatment. Sample size: The number of neonates to be included in this study is based on data (mortality - brain injury) derived of neonatal centres in Graz (Austria), Rotterdam (Netherlands) and Edmonton (Canada) and is estimated to be 724 preterm infants. Interventions: Preterm neonates included into this study are randomized into a study group and control group. In both groups, the oxygen saturation of the brain (on the forehead), the arterial oxygen saturation (on the right hand) and the heart rate (on the breast) are transcutaneously measured starting within three minutes after birth. In the study group, the oxygen saturation of the brain is visible along with the other measurements, and premature babies are treated according to defined treatment guidelines concerning respiratory / circulatory support and oxygen support during the immediate transition after birth. In the control group oxygen saturation of the brain is not visible and only the arterial oxygen saturation and heart rate will be displayed, and premature babies are treated according to the routine. The study will be conducted during the first 15 minutes after birth. Follow-up: Until the discharge or term age of the preterm neonates. Primary outcome parameter is survival without brain injury (defined as intraventricular haemorrhage or cystic lesions of the brain) Secondary outcome parameters are severe diseases and neurological outcome of the preterm neonates. Originality of study: First prospective multi-centre study including a large number of preterm neonates, in whom oxygen saturation of the brain is used to guide treatment during immediate transition after birth.