SafeBoosC-II kicked off at a small meeting in Dragør, near Copenhagen airport 2-3 April 2009. We sent several applications for funding without success, while the project gradually matured. We formed the putative causal chain:
Monitoring of cerebral oxygenation in extremely preterm babies and modification of cardio-respiratory support trying to normalise of out-of-range values leads to:
- a reduced burden of cerebral hypoxia and hyperoxia
which leads to
- less brain injury (indicated by EEG suppression, blood molecular biomarkers of brain injury, and ultrasound and MRI imaging)
which in turn leads to
- reduced neurodevelopmental impairment (the patient-relevant outcome)
This was tested in a pilot trial in 10 babies, and in a randomized clinical phase-II trial in 166 babies which proved the first step above. The burden of cerebral hypoxia could be reduced to less than half.
The consortium grew to the 19 members behind the SafeBoosC-III trial who submitted a protocol for EU funding in 2015 to test the next step above. Early 2018 the Elsass Foundation funded the initial clinical trial center costs, and by the end of 2019 a large, pragmatic trial has started to enroll the 800+800 babies needed to demonstrate a reduction in the risk of death or severe brain injury from 34% to 26%.