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 with intervention 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).
The final form was a pilot trial with 10 patients, and a randomized clinical phase-II trial with burden of cerebral hypoxia and hyperoxia as the primary outcome. This has now been completed and 2-year follow-up is ongoing.
Click here to read more about SafeBoosC-II.