Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
Recruiting now · Phase 3
Conditions studied: Hypoxia, Infant, Newborn, Diseases
In brief
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.
Key facts
- Study ID
- NCT05907317
- Run by
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- People needed
- 1610
- Starts
- 2025-04-11
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2025-04-25
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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