NCT05907317 Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
| NCT ID | NCT05907317 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Copenhagen Trial Unit, Center for Clinical Intervention Research |
| Condition | Hypoxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,610 participants |
| Start Date | 2025-04-11 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,610 participants in total. It began in 2025-04-11 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05907317 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 28 Days, studying Hypoxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05907317 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,610 participants.
Is NCT05907317 currently recruiting?
Yes, NCT05907317 is actively recruiting participants. Contact the research team at caroline.kamp@ctu.dk for enrollment information.
Where is the NCT05907317 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT05907317 clinical trial?
NCT05907317 is sponsored by Copenhagen Trial Unit, Center for Clinical Intervention Research. The trial plans to enroll 1,610 participants.