Monitoring brain oxygen levels in newborns on mechanical ventilation
Official title: Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns
Run by Copenhagen Trial Unit, Center for Clinical Intervention Research · NCT05907317 · Data updated 2026-11-12
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 | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Enrollment | 1610 (estimated) |
| Sponsor | Copenhagen Trial Unit, Center for Clinical Intervention Research Academic / other |
| Locations | 1 site (Madrid) |
| Status | Recruiting |
| Started | April 11, 2025 |
| Main results expected | February 1, 2029 |
| Study ends | February 1, 2029 |
| Registry record updated | April 25, 2025 |
| Trial ID | NCT05907317 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include newborns aged less than 28 days who are expected to receive invasive mechanical ventilation for at least 24 hours.
✕Probably not a fit
Patients with confirmed brain injuries or congenital heart malformations likely to require surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promise in using cerebral oximetry for monitoring brain health in similar populations, suggesting potential for success.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
How the body responds to exercise with low oxygen in healthy adults
Researchers test how healthy men and women respond to different exercise types while breathing air with varying oxygen levels.
-
How acute low-oxygen levels affect the right side of the heart in asthma
This study tests how short-term exposure to simulated high-altitude oxygen levels affects right heart function in adults with asthma.
-
How short-term low oxygen exposure affects the right side of the heart in healthy adults
We test whether short-term reduced oxygen (simulated 2,500 m and 4,000 m) changes right ventricular function in healthy adults at rest and during light exercise.
-
Right-heart response to short-term low oxygen in people with past HAPE
This trial tests whether brief exposure to simulated high altitude (low oxygen) changes right-heart function in adults who previously had high-altitude pulmonary edema (HAPE).
-
Supraglottic oxygen through a thin nasal tube during deep-sedation bronchoscopy
This trial tests whether inserting a thin, wired endotracheal tube through the nose to deliver oxygen above the vocal cords helps prevent low oxygen levels in adults undergoing deep-sedation fiberoptic bronchoscopy.
-
High-flow nasal oxygen to prevent low oxygen during sedated endoscopy in people with high-risk sleep apnea
This will test whether using high‑flow nasal oxygen instead of a regular nasal cannula prevents low oxygen levels during propofol‑sedated gastroscopy or colonoscopy in adults with high‑risk obstructive sleep apnea (STOP‑Bang ≥5).
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.