Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)

Launched by COPENHAGEN TRIAL UNIT, CENTER FOR CLINICAL INTERVENTION RESEARCH · Jun 8, 2023

Keywords

ClinConnect Summary

The SafeBoosC-IIIv trial is a study designed to help improve the care of newborns who need breathing support through a machine called invasive mechanical ventilation. Researchers want to find out if using a special monitor called cerebral oximetry, which measures the oxygen levels in the brain, can provide benefits compared to standard care alone. They hope that this additional monitoring will lead to more days without hospital stays for these babies within 90 days and will reduce the chances of serious issues like death or developmental delays by the time the children reach two years old.

To be eligible for this trial, newborns must be at least 28 weeks old, be less than 28 days old, and need to be on mechanical ventilation for at least 24 hours, as determined by their doctor. Parents must give permission for their child to participate, and the monitoring must start within six hours of beginning ventilation. However, babies with certain serious conditions like brain injuries or heart problems that may need surgery cannot join. If you decide to participate, your child will receive careful monitoring and support throughout the study to understand the potential benefits of this new approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Gestational age more than or equal to 28+0
• • Postnatal age less than 28 days
• • Expected to receive invasive mechanical ventilation (intubation) for at least 24 hours, as judged by the physician intending to randomise
• • Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method
• • A cerebral oximeter available so monitoring can be started within six hours after initiation of invasive mechanical ventilation
• Exclusion Criteria:
• • Suspicion of or confirmed brain injury or disorder (e.g. severe hypoxic-ischemic encephalopathy, intraventricular haemorrhage grade 3 or 4, cerebral malformation, genetic or metabolic disease)
• • Suspicion or diagnosis of congenital heart malformations likely to require surgery