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

Description

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.

Study Start Date

May, 01 2015

Estimated Completion Date

June 2018

Interventions

  • Device: Resonance Raman Spectroscopy (RRS)

Study ID

University of Florida -- IRB201601508

Status

Recruiting

Trial ID

NCT03277768

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

100

Sponsor

University of Florida

Inclusion Criteria

  • Infants < 30 weeks estimated gestational age

Exclusion Criteria

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

Gender

All

Ages

N/A

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles None None None
University of Florida - Gainesville, Florida 1,081.3 miles None None None

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