- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277768
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
September 6, 2019 updated by: University of Florida
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Premature infants born <30 weeks gestational age and admitted to the Boston Children's Hospital neonatal intensive care unit (NICU), Brigham and Women's NICU, and the University of Florida NICU.
Description
Inclusion Criteria:
- Infants < 30 weeks estimated gestational age
Exclusion Criteria:
- Infants with major congenital anomalies
- Infants >34 weeks post-menstrual age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control Group -Patent Ductus Arteriosus Absent
|
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
|
Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to a maximum of 14 data collection times
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to a maximum of 14 data collection times
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: J Lauren Ruoss, MD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
August 23, 2018
Study Registration Dates
First Submitted
September 1, 2017
First Submitted That Met QC Criteria
September 6, 2017
First Posted (Actual)
September 11, 2017
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 6, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201601508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The analysis of the data will be shared with other research.
Individual patient data will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patent Ductus Arteriosus
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PFM Medical, IncBright Research PartnersCompleted
-
Abbott Medical DevicesCompletedPatent Ductus Arteriosus (PDA)United States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedPatent Ductus Arteriosus | Patent Ductus Arteriosus After Premature Birth | Patent Ductus Arteriosus - Delayed ClosureItaly, United Kingdom
-
Ankara UniversityCompletedPatent Ductus Arteriosus in Preterm InfantsTurkey
-
Nada YoussefCompletedPatent Ductus Arteriosus After Premature Birth | Patent Ductus Arteriosus Conservative ManagementEgypt
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Abbott Medical DevicesNo longer availablePatent | Ductus | Arteriosus
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University of FlorenceCompletedDuctus Arteriosus, PatentItaly
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National Taiwan University HospitalCompletedPatent Ductus Arteriosus
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