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

Copenhagen Trial Unit, Center for Clinical Intervention Research

Status and phase: Enrolling; Phase 3

Conditions: Hypoxia; Infant, Newborn, Diseases

Treatments: Other: Usual care; Device: Cerebral oximetry monitoring device

Study type: Interventional

Funder types: Other

Identifiers

NCT05907317

SafeBoosC-IIIv

Details and patient eligibility

About

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.

Full description

SafeBoosC-IIIv will be an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. The trial will be conducted in two steps. In step one, 1,610 newborns will be randomised, and the outcomes will be assessed 90 days after randomisation. Funding has been obtained for step one. If further funding is obtained, we will continue to include newborns until a total of 3,000 newborns are randomised and then follow them up at two years of corrected age (step two).

Enrollment: 1,610 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,610 participants in 2 patient groups

Cerebral oximetry + usual care

Experimental group

Treatment:

Device: Cerebral oximetry monitoring device

Other: Usual care

Usual care

Other group

Description:

The control group will receive mechanical ventilation without access to cerebral oximetry and the SafeBoosC treatment guideline. If the newborn is cared for outside the neonatal unit at any time, e.g. during surgery, cerebral oximetry may or may not be used, as decided by the responsible physician there

Treatment:

Other: Usual care