SafeBoosC-III

Safeguarding the brain of our smallest children – a phase III randomised clinical trial on near-infrared spectroscopy monitoring combined with a treatment guideline in premature infants with clinically relevant outcomes

We conduct a large, pragmatic trial in extremely preterm babies to examine if cerebral oximetry combined with a treatment guideline can reduce the risk of death or severe brain injury at 36 weeks of age from 34% in the control group to 26% in the experimental group.

We use oximeters that is approved for clinical use and that have been calibrated in the blood-lipid phantom to define the hypoxic threshold for clinical action. This makes it a trial of the generic principle of tissue oximetry-guided therapy. 
By June 2020, 46 hospitals have started randomising and more than 300 babies have been included. An additional 27 hospitals have ethics approval and are preparing for participation as well.


The preparation log will be continuously updated. Below you will find a figure illustrating the trials’ randomisation rate from June 2019 and until June 2020.




All materials are available at this website in public space.




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