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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-11

Study Completion Date

2029-02-01

Brief Summary

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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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Detailed Description

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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).

Conditions

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Hypoxia Infant, Newborn, Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The trial will recruit 1610 babies in step one. Randomisation will continue until 3000 babies are recruited in step two.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Step one: The primary outcome will be assessed by a blinded investigator. The principal investigator from each centre must develop a local blinding procedure, describing how blinding is achieved. To support the principal investigators in this work, a Standard Operation Procedure with suggestions for blinding procedures will be developed. Data managers, statisticians, and conclusion drawers will be blinded.

Step two: Due to the nature of the experimental intervention, clinical staff and the parents will not be blinded to group allocation. Thus, the primary outcome will not be blinded in cases when it relies on parental reporting. If there is no contact with the parents, or if they do not return the questionnaire, data will be collected from health care records. Investigators reviewing the health care records will, if possible, be blinded to the allocated intervention. Data managers, statisticians, and conclusion drawers will be blinded.

Study Groups

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Cerebral oximetry + usual care

Group Type EXPERIMENTAL

Cerebral oximetry monitoring device

Intervention Type 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

Intervention Type OTHER

Treatment as usual

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

Group Type OTHER

Usual care

Intervention Type OTHER

Treatment as usual

Interventions

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Cerebral oximetry monitoring 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.

Intervention Type DEVICE

Usual care

Treatment as usual

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No