Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
Trial Parameters
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