Safeguarding the brain of our smallest children – testing if monitoring of cerebral oxygenation by near-infrared spectroscopy and combining this with a treatment guideline can improve the chances of survival without brain injury and neurodevelopmental impairment in extremely preterm infants


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.