Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-28
SponsorCopenhagen Trial Unit, Center for Clinical Intervention Research
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 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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cerebral oximetry monitoring device
- Usual care
Treatment groups
1,610 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov