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

NCT03277768 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2019-09-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • J Lauren Ruoss, MD · University of Florida

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2017-09-30
Completion
2018-08-23

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03277768 on ClinicalTrials.gov