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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,610

Participants

Timeline

Start Date

April 11, 2025

Primary Completion Date

February 1, 2029

Study Completion Date

February 1, 2029

Conditions
HypoxiaInfant, Newborn, Diseases
Interventions
DEVICE

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.

OTHER

Usual care

Treatment as usual

Trial Locations (1)

Unknown

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

All Listed Sponsors
lead

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER