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Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
Summary
The objective of the SafeBoosC-IIIv trial is to assess benefits and harms of cerebral oximetry in newborns receiving invasive mechanical ventilation. The hypothesis is that: i. Cerebral oximetry added to usual care versus usual care alone in newborns receiving invasive mechanical ventilation will increase the number of hospital-free days within 90 days of randomisation. ii. The intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and/or increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.
Official title: Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns
Key Details
Gender
All
Age Range
0 Days - 28 Days
Study Type
INTERVENTIONAL
Enrollment
1610
Start Date
2025-04-11
Completion Date
2029-02-01
Last Updated
2025-04-25
Healthy Volunteers
No
Conditions
Interventions
Cerebral oximetry monitoring device
Participants in the experimental group will be monitored with cerebral oximetry, if possible before or, as soon as possible and within six hours after initiation of invasive mechanical ventilation. Cerebral oximetry will be continued until 1) the cardio-pulmonary function has been stabilised as indicated by the need for respiratory and circulatory support and evaluated by the responsible physician, 2) extubation, 3) until 28 days after birth, or 4) until death. Randomisation will only direct the use of cerebral oximetry during the first invasive mechanical ventilation episode. Cerebral oximetry will be used to minimise cerebral hypoxia by modifying clinical care according to the SafeBoosC treatment guideline and monitoring as usual.
Usual care
Treatment as usual
Locations (1)
Hospital Universitario 12 de Octubre
Madrid, Spain