SafeBoosC

Safeguarding the brain of our smallest children – testing if monitoring of cerebral oxygenation by near-infrared spectroscopy combined with a treatment guideline can improve the chances of extremely preterm babies to        survive without neurodevelopmental deficit 

SafeBoosC-II​​

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.
 

SafeBoosC-III

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%.





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