Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)
- Conditions
- Infant, Newborn, DiseasesHypoxia
- Interventions
- Other: Usual careDevice: Cerebral oximetry monitoring device
- Registration Number
- NCT05907317
- Lead Sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1610
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Usual care 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 Cerebral oximetry + usual care Cerebral oximetry monitoring device - Cerebral oximetry + usual care Usual care -
- Primary Outcome Measures
Name Time Method Hospital-free days within 90 days of randomisation 90 days Primary outcome for step one
Parental questionnaires 18-30 months Co-primary outcome for step two: Parental questionnaires completed between 18-30 months' corrected age as well as available data from at least 12 months' corrected age from health care records, including standardised neurodevelopmental assessments, will be used to assess mortality and neurodevelopment.
• Non-verbal cognitive score of Parent Report of Children's Abilities-Revised (PARCA-R), a parental questionnaire, at two years of corrected age (range 0-34, higher score means better outcome).A composite of death from any cause or moderate to severe neurodevelopmental disability 2 years Co-primary outcome for step two
A composite of death from any cause or moderate to severe neurodevelopmental disability at two years of corrected age. Moderate to severe neurodevelopmental disability will be defined as one or more of the following
1. cerebral palsy with Global Motor Function Classification System level 2 or higher;
2. a Parent Report of Children's Abilities-Revised (PARCA-R) non-verbal cognitive function score (range 0-34, higher score means better outcome) below -2 standard deviations (SD);
3. hearing loss corrected with aids or worse; or
4. vision impairment defined as moderately reduced vision of one eye, or only being able to perceive light or light reflecting objects; or blind in one eye with good vision in the contralateral eye.
- Secondary Outcome Measures
Name Time Method Invasive mechanical ventilation-free days within 90 days of randomisation 90 days Secondary outcome for step one
Proportion of participants with a serious adverse event 90 days Secondary outcome for step one: Proportion of participants with one or more Serious Adverse Events within the 90 days of randomization, i.e. one or more of the following:
Death from any cause Bronchopulmonary dysplasia (BPD) Any brain injury diagnosed by imaging Seizures treated with antiepileptic medicine Haemodynamic insufficiency that needs cardiovascular support Spontaneous bowel perforation or necrotising enterocolitis (NEC) Bells grade 2 or more Nosocomial infection Extra Corporal Membrane Oxygenation (ECMO) Renal replacement therapy
Trial Locations
- Locations (1)
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain