Brief Title
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
Official Title
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
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.
Study Type
Observational
Primary Outcome
Differences and pre- and post-ductal RRS measurements of tissue oxygenation.
Secondary Outcome
Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.
Condition
Premature Infant
Intervention
Resonance Raman Spectroscopy (RRS)
Study Arms / Comparison Groups
Control Group -Patent Ductus Arteriosus Absent
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
55
Start Date
May 1, 2015
Completion Date
August 23, 2018
Primary Completion Date
September 2017
Eligibility Criteria
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 - N/A
Contacts
J Lauren Ruoss, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03277768
Organization ID
IRB201601508
Responsible Party
Sponsor
Study Sponsor
University of Florida
Collaborators
Boston Children's Hospital
Study Sponsor
J Lauren Ruoss, MD, Principal Investigator, University of Florida
Verification Date
September 2019