RecruitingPhase 3NCT05907317

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

Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns

Sponsor

Copenhagen Trial Unit, Center for Clinical Intervention Research

Enrollment

1,610 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

Hypoxia Infant, Newborn, Diseases

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

Min Age: 0 DaysMax Age: 28 Days

Inclusion Criteria5

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 Criteria2

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

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Interventions

DEVICECerebral oximetry monitoring device

Participants in the experimental group will be monitored with cerebral oximetry, if possible before or, as soon as possible and within six hours after initiation of invasive mechanical ventilation. Cerebral oximetry will be continued until 1) the cardio-pulmonary function has been stabilised as indicated by the need for respiratory and circulatory support and evaluated by the responsible physician, 2) extubation, 3) until 28 days after birth, or 4) until death. Randomisation will only direct the use of cerebral oximetry during the first invasive mechanical ventilation episode. Cerebral oximetry will be used to minimise cerebral hypoxia by modifying clinical care according to the SafeBoosC treatment guideline and monitoring as usual.

OTHERUsual care

Treatment as usual