Clinical trials

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Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 1,610
Trial details
Phase: Phase 3Age: 0-28Biological sex: AllType: InterventionalSponsor: Copenhagen Trial Unit, Center for Clinical Intervention ResearchUpdated: Apr 25, 2025Locations: 1
Eligibility criteria

Gestational age more than or equal to 28+0 [+4]

Suspicion of or confirmed brain injury or disorder (e.g. severe hypoxic-ischemic... [+1]