Health TrialsbyHealthPanel

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

ConditionsHypoxiaInfant, Newborn, Diseases
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-28
SponsorCopenhagen Trial Unit, Center for Clinical Intervention Research

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cerebral oximetry monitoring device

    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.

  • Usual care

    Other intervention

    Treatment as usual

Treatment groups

1,610 Participants
are divided into 2 treatment groups
Group A: Cerebral oximetry + usual careExperimental treatment 2 interventions
Group B: Usual careOther 1 intervention

Trial outcomes

Primary outcomes

1

Hospital-free days within 90 days of randomisation

Primary outcome for step one

Time frame
90 days
2

A composite of death from any cause or moderate to severe neurodevelopmental disability

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.

Time frame
2 years
3

Parental questionnaires

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).

Time frame
18-30 months

Secondary outcomes

1

Proportion of participants with a serious adverse event

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

Time frame
90 days
2

Invasive mechanical ventilation-free days within 90 days of randomisation

Secondary outcome for step one

Time frame
90 days

Other outcomes

1

Late onset sepsis

Exploratory outcome for step one

Time frame
90 days
2

Invasive mechanical ventilation-related infection

Exploratory outcome for step one

Time frame
90 days
3

Cerebral palsy

Exploratory outcome for step two: defined as Global Motor Function Classification System level 2 or above, at two years of corrected age.

Time frame
2 years
4

Sensory deficit

exploratory outcome for step two: defined as any degree of vision or hearing impairment, at two years of corrected age.

Time frame
2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Copenhagen Trial Unit, Center for Clinical Intervention Research

Lead sponsor

Source ClinicalTrials.gov
Apply now