SafeBoosc-III
Research type
Research Study
Full title
Safe guarding the Brain Of Our Smallest Children-III Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants. A multinational randomised, pragmatic phase III clinical trial.
IRAS ID
275529
Contact name
Anne Marie Heuchan
Contact email
Sponsor organisation
Region Hovedstaden
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The premature brain is vulnerable to injury, particularly in the hours after birth. Currently, for infants born at < 28 weeks gestation there is a 20% chance of death and about 25% live with either cerebral palsy or learning difficulties. In pilot trials(SafeBoosC-II),visible early brain (cerebal)oxygen monitoring, using near-infrared spectroscopy(NIRS),significantly reduced low brain oxygen levels(hypoxia)in preterm infants, compared with a control group. This was associated with encouraging reductions in death and brain injury. Brain NIRS is used in adult and paediatric intensive care. Commercially available equipment is available for preterm infants, and is in use in some centres, but large clinical trials have not been undertaken. The aim of the SafeBoosC-III trial is to investigate the benefits and harms of brain NIRS monitoring in the first 72 hours of life compared with treatment as usual for extremely preterm infants. SafeBoosC III is a multinational, randomised, pragmatic phase III clinical trial for infants born below 28 weeks postmenstrual age and recruited within the first 6 hours of life. Participants in the experimental group will be monitored during the first 72 hours of life with a brain NIRS oximeter. If brain hypoxia is identified doctors will try to improve this with standard clinical interventions. Participants in the control group will not undergo brain oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Scans will be be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants internationally.
REC name
West of Scotland REC 5
REC reference
20/WS/0033
Date of REC Opinion
25 Feb 2020
REC opinion
Favourable Opinion