Safeguarding the Brains of Our Smallest Children - a Pilot Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- change of medical management elicited by cerebral oxygenation out of range
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- — to 3 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
cerebral oximetry + treatment guideline
Cerebral oximetry applied as soon as possible after birth and continued until 72 hours of life Clinical staff administer the routine medical management according to local practice as well as respond to out-of-range values with the help of the treatment guideline
Intervention: cerebral oximeter (Device)
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)
Investigators
Gorm Greisen
professor,head of department
Rigshospitalet, Denmark