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 18th of September 2021, 72 hospitals have started randomising and 1360 babies have been included. An additional 10 hospitals 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 18th of June 2019 and until 18th of September 2021.
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