Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
Recruiting
Phase 3
Interventional Study
Hypoxia
Infant, Newborn, Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 Days – 28 Days
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,610 (estimated)
- Sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention Research · Other
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About This Trial
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…
Trial Locations
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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 …
Contacts