Clinical trial NCT05907317: Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
Official title: Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypoxia
Infant, Newborn, Diseases
Keywords: Near-infrared spectroscopy
Randomised clinical trial
Mechanical ventilation
Lead sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 1610
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial will recruit 1610 babies in step one. Randomisation will continue until 3000 babies are recruited in step two.
Primary purpose: TREATMENT

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.

Detailed 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).

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

Primary outcomes:
measure: Hospital-free days within 90 days of randomisation
timeFrame: 90 days
measure: A composite of death from any cause or moderate to severe neurodevelopmental disability
timeFrame: 2 years
measure: Parental questionnaires
timeFrame: 18-30 months
Secondary outcomes:
measure: Proportion of participants with a serious adverse event
timeFrame: 90 days
measure: Invasive mechanical ventilation-free days within 90 days of randomisation
timeFrame: 90 days
Other outcomes:
measure: Late onset sepsis
timeFrame: 90 days
measure: Invasive mechanical ventilation-related infection
timeFrame: 90 days
measure: Cerebral palsy
timeFrame: 2 years
measure: Sensory deficit
timeFrame: 2 years
measure: All-cause mortality
timeFrame: 2 years
measure: Use of daily medication
timeFrame: 2 years
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
References:
citation: Vestager ML, Hansen ML, Rasmussen MI, Hahn GH, Hyttel-Sorensen S, Pellicer A, Heuchan AM, Hagmann C, Dempsey E, Dimitriou G, Pichler G, Naulaers G, Fuchs H, Tkaczyk J, Mintzer J, Fumagalli M, Nesargi S, Fredly S, Szczapa T, Gluud C, Jakobsen JC, Greisen G. The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial. Trials. 2023 Oct 28;24(1):696. doi: 10.1186/s13063-023-07699-x.