NCT05907317

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

Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,610 (estimated)
• Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Not accepted

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.

Detailed description

SafeBoosC-IIIv will be an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. The trial will be conducted in two steps. In step one, 1,610 newborns will be randomised, and the outcomes will be assessed 90 days after randomisation. Funding has been obtained for step one. If further funding is obtained, we will continue to include newborns until a total of 3,000 newborns are randomised and then follow them up at two years of corrected age (step two).

Conditions

• Hypoxia
• Infant, Newborn, Diseases

Interventions

Type	Name	Description
DEVICE	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.
OTHER	Usual care	Treatment as usual

Timeline

• Start date: 2025-04-11
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2023-06-18
• Last updated: 2025-04-25

Locations

1 site across 1 country: Spain