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 the 16th of December 2021, recruitment was completed and a total of 1601 babies have been randomised across 70 centres in 17 countries. The results have been submitted for publication in June 2022. An overview of the process from completion of recruitment to submission of the final manuscript can be found here.​
 
An overview of randomisations across all the recruiting centres can be found here.
  
Below you will find a figure illustrating the trials’ randomisation rate from 18th of June 2019 and until 16th of December 2021.



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