NCT03277768

Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Premature Infant
• Patent Ductus Arteriosus
• Hemodynamic Instability

Interventions

Type	Name	Description
DEVICE	Resonance Raman Spectroscopy (RRS)	Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-09-01
• Completion: 2018-08-23
• First posted: 2017-09-11
• Last updated: 2019-09-10

Locations

2 sites across 1 country: United States