Safeguarding the Brains of Our Smallest Children - a Pilot Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Premature Infants
- Sponsor
- Gorm Greisen
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- change of medical management elicited by cerebral oxygenation out of range
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.
Investigators
Gorm Greisen
professor,head of department
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •gestational age at birth less than 28 completed weeks
- •cerebral oximeter in place at 3 hours after birth
Exclusion Criteria
- •decision not to provide full life support
Outcomes
Primary Outcomes
change of medical management elicited by cerebral oxygenation out of range
Time Frame: 0-72 hours of life
Recording of the type of change of management as defined by the treatment guideline
Secondary Outcomes
- Adverse device effects(0-72 hours)
- burden of hypo-and hyperoxia(0-72 hours)