NCT01530360

Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

Safeguarding the Brains of Our Smallest Children - a Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Gorm Greisen · Academic / Other
• Sex: All
• Age: 3 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Infants
• Near-infrared Spectroscopy
• Oximetry

Interventions

Type	Name	Description
DEVICE	cerebral oximeter	INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2012-03-01
• First posted: 2012-02-09
• Last updated: 2012-12-10

Locations

1 site across 1 country: Denmark