Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

Phase 1

Completed

• Conditions: Premature Infants; Near-infrared Spectroscopy; Oximetry

• Registration Number: NCT01530360
• Lead Sponsor: Gorm Greisen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-12
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-09
• Study Completion: 2012-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-07
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
change of medical management elicited by cerebral oxygenation out of range	0-72 hours of life	Recording of the type of change of management as defined by the treatment guideline

Secondary Outcome Measures

Name	Time	Method
Adverse device effects	0-72 hours	Expected and unexpected
burden of hypo-and hyperoxia	0-72 hours	measured as %hours out of the target range (55-85%)

Trial Locations

Locations (1)

Department of Neonatology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark