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

Completed

• Conditions: Hemodynamic Instability; Patent Ductus Arteriosus; Premature Infant
• Interventions: Device: Resonance Raman Spectroscopy (RRS)

• Registration Number: NCT03277768
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2017-09
• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-11
• Study Completion: 2018-08-23
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Infants < 30 weeks estimated gestational age

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Exclusion Criteria

• Infants with major congenital anomalies
• Infants >34 weeks post-menstrual age

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group -Patent Ductus Arteriosus Absent	Resonance Raman Spectroscopy (RRS)	-
Study Group - Patent Ductus Arteriosus Present	Resonance Raman Spectroscopy (RRS)	-

Primary Outcome Measures

Name	Time	Method
Differences and pre- and post-ductal RRS measurements of tissue oxygenation.	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 Outcome Measures

Name	Time	Method
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	RRS measurements and the difference between pre- and post-ductal tissue oxygenation will be evaluated in infants with serious adverse events to determine if the measurements could have predicted the serious adverse event.

Trial Locations

Locations (2)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States