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NCT Number: NCT05907317

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

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.

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Key information

Conditions

Hypoxia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location status: Recruiting

Location contact

Doctor

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Treatment as usual

Primary outcomes

  1. Hospital-free days within 90 days of randomisation

    Time frame: 90 days

    Primary outcome for step one

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

    Time frame: 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

    • cerebral palsy with Global Motor Function Classification System level 2 or higher;
    • 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);
    • hearing loss corrected with aids or worse; or
    • 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.

  3. Parental questionnaires

    Time frame: 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).

Secondary outcomes

  1. Proportion of participants with a serious adverse event

    Time frame: 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

  2. Invasive mechanical ventilation-free days within 90 days of randomisation

    Time frame: 90 days

    Secondary outcome for step one

Other outcomes

  1. Late onset sepsis

    Time frame: 90 days

    Exploratory outcome for step one

  2. Invasive mechanical ventilation-related infection

    Time frame: 90 days

    Exploratory outcome for step one

  3. Cerebral palsy

    Time frame: 2 years

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

  4. Sensory deficit

    Time frame: 2 years

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

  5. All-cause mortality

    Time frame: 2 years

    Exploratory outcome for step two: Mortality at two years of corrected age.

  6. Use of daily medication

    Time frame: 2 years

    Exploratory outcome for step two: Use of medication during the last two months, at two years of corrected age.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Kamp, PhD

CONTACT

[email protected]

+45 20 32 41 08

Johanne Juul Petersen

CONTACT

[email protected]

+45 28 93 30 35

Sponsors and collaborators

Lead sponsor

Copenhagen Trial Unit, Center for Clinical Intervention Research

Other

Registry information

Official study title

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

Acronym: SafeBoosC-IIIv

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 18, 2023
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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