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 infants 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 patients, and a randomized clinical phase-II trial in 166 patients with the burden of cerebral hypoxia and hyperoxia as the primary outcome. Two-year follow-up of the phase-II trial has now been published.
The consortium grew from the initial 5 members to the 19 members behind the SafeBoosC-III trial with survival without brain injury as the primary outcome that was submitted for EU funding in 2015. The plan is to enroll 800+800 infants. Early 2018 the Elsass Foundation funded the clinical trial centre costs, and work has started to get ready.