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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Infant Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Hemodynamic Instability Obstetric Labor Complications Obstetric Labor, Premature Patent Ductus Arteriosus Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, Gainesville, Florida, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Infants < 30 weeks estimated gestational age

Exclusion criteria

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

Treatment and study plan

Resonance Raman Spectroscopy (RRS)

Device

Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.

Primary outcomes

Differences and pre- and post-ductal RRS measurements of tissue oxygenation.

Time frame: 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 outcomes

Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

Boston Children's Hospital

Registry information

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2018
First posted: Sep 11, 2017
Registry last updated: Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed