Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

Phase 1

Completed

• Conditions: Premature Infants; Near-infrared Spectroscopy; Oximetry
• Interventions: Device: cerebral oximeter

• 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

Arm && Interventions

Group	Intervention	Description
cerebral oximetry + treatment guideline	cerebral oximeter	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

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