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Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants — SafeBoosC-p  

Premature Infants Clinical Trial

Official title:
Safeguarding the Brains of Our Smallest Children - a Pilot Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01530360
Study type Interventional
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase Phase 1
Start date September 2011
Completion date March 2012
View Details
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