Safeguarding the Brain Of Our Smallest Children – an open-label phase-III randomized trial of cerebral oximetry combined with a treatment guideline versus treatment as usual in premature infants.
Study ID: STU-2019-1707
each year, 50,000 extremely preterm infants are born in high-income countries with access to neonatal intensive care. of these, 10,000 will die and a further 10,000 will suffer cerebral palsy or moderate-to-severe neuro-cognitive disability. Time spent outside normal cerebral oxygenation ranges (time with hypoxia or hyperoxia) is associated with poor neurological outcome in children and adults. Monitoring of cerebral oxygenation may reduce the risk of cerebral complications, but no such effects have yet been demonstrated in preterm infants in large randomised clinical trials. The recently completed SafeBoosC phase ii trial was conducted at eight sites in eight european countries. 166 extremely preterm infants were randomised to visible monitoring of cerebral oxygenation by near-infrared spectroscopy (niRS) combined with an evidence-based treatment guideline (experimental group) versus blinded niRS and treatment as usual (control group). The trial found that niRS monitori[See protocol for complete text]
The overall objective of the SafeBoosC-iii trial is to investigate the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual. The hypothesis is that treatment based on near-infrared spectroscopy monitoring for extremely preterm infants during the first 72 hours of life will result in a reduction in severe brain injury or death at 36 weeks postmenstrual age.