Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Infant
- Sponsor
- University of Florida
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at < 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants \< 30 weeks estimated gestational age
Exclusion Criteria
- •Infants with major congenital anomalies
- •Infants \>34 weeks post-menstrual age
Outcomes
Primary Outcomes
Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
Time Frame: Up to a maximum of 14 data collection times
Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.
Secondary Outcomes
- Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.(Up to a maximum of 14 data collection times)