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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277768
• Other study ID #: IRB201601508
• Status: Completed
• Start date: May 1, 2015
• Est. completion date: August 23, 2018

Study information

• Verified date: September 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 23, 2018
• Est. primary completion date: September 2017
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Infants < 30 weeks estimated gestational age

Exclusion Criteria:

• Infants with major congenital anomalies

• Infants >34 weeks post-menstrual age

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Hemodynamic Instability
• Patent Ductus Arteriosus
• Premature Birth
• Premature Infant

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences and pre- and post-ductal RRS measurements of tissue oxygenation.	Pre- and post-ductal tissues oxygenation as measured by RRS may be more significant in infants with PDA.	Up to a maximum of 14 data collection times
Secondary	Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.	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.	Up to a maximum of 14 data collection times