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

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT03277768
• Collaborator: Boston Children's Hospital (Other)
• Enrollment: 55
• Locations: 2
• Actual Duration (Months): 39.8
• Patients Per Site: 27.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Infant; Patent Ductus Arteriosus; Hemodynamic Instability	Device: Resonance Raman Spectroscopy (RRS)

Study Design

• Study Type: Observational
• Actual Enrollment: 55 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Aug 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Control Group -Patent Ductus Arteriosus Absent	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.
Study Group - Patent Ductus Arteriosus Present	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Infants < 30 weeks estimated gestational age

Exclusion Criteria:

• Infants with major congenital anomalies

• Infants >34 weeks post-menstrual age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610
2	Boston Children's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• University of Florida
• Boston Children's Hospital

Investigators

• Principal Investigator: J Lauren Ruoss, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03277768
• Other Study ID Numbers: IRB201601508
• First Posted: Sep 11, 2017
• Last Update Posted: Sep 10, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Florida: Premature infant; Tissue Oxygenation; Patent Ductus Arteriosus
• Additional relevant MeSH terms: Premature Birth; Ductus Arteriosus, Patent

Study Results

No Results Posted as of Sep 10, 2019