Actively Recruiting
Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
Led by Copenhagen Trial Unit, Center for Clinical Intervention Research · Updated on 2025-04-25
1610
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age more than or equal to 28+0
- Postnatal age less than 28 days
- Expected to receive invasive mechanical ventilation for at least 24 hours as judged by the physician
- Parental informed consent obtained unless opt-out or deferred consent is used
- Availability of a cerebral oximeter to start monitoring within six hours after invasive mechanical ventilation begins
You will not qualify if you...
- Suspicion or confirmation of brain injury or disorder such as severe hypoxic-ischemic encephalopathy, severe intraventricular haemorrhage, cerebral malformation, genetic or metabolic disease
- Suspicion or diagnosis of congenital heart malformations likely requiring surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
Research Team
C
Caroline Kamp, PhD
CONTACT
J
Johanne Juul Petersen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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