Monitoring brain oxygen levels in newborns on mechanical ventilation
Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns
PHASE3 · Copenhagen Trial Unit, Center for Clinical Intervention Research · NCT05907317
This study is testing if using a special brain oxygen monitor can help newborns on breathing machines have better health and brain development compared to standard care alone.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1610 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | Copenhagen Trial Unit, Center for Clinical Intervention Research (other) |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05907317 on ClinicalTrials.gov |
What this trial studies
The SafeBoosC-IIIv trial aims to evaluate the effects of cerebral oximetry monitoring in newborns who are receiving invasive mechanical ventilation. This phase III clinical trial will randomize 1,610 newborns to either receive standard care or standard care plus cerebral oximetry, with outcomes assessed at 90 days post-randomization. If additional funding is secured, the trial will expand to include a total of 3,000 newborns and follow them for two years to assess long-term neurodevelopmental outcomes. The primary hypothesis is that cerebral oximetry will lead to more hospital-free days and improved cognitive scores.
Who should consider this trial
Good fit: Ideal candidates include newborns aged less than 28 days who are expected to receive invasive mechanical ventilation for at least 24 hours.
Not a fit: Patients with confirmed brain injuries or congenital heart malformations likely to require surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for newborns requiring mechanical ventilation.
How similar studies have performed: Previous studies have shown promise in using cerebral oximetry for monitoring brain health in similar populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Madrid
- Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Caroline Kamp, PhD
- Email: caroline.kamp@ctu.dk
- Phone: +45 20 32 41 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypoxia, Infant, Newborn, Diseases, Near-infrared spectroscopy, Randomised clinical trial, Mechanical ventilation