Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure

January 18, 2019 updated by: Kate Tauber, Albany Medical College

Use of Near Infrared Spectroscopy in Preterm Infants to Determine Patent Ductus Arteriosus Closure Following Medical Treatment

Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4

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

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center Neonatal Intesive Care Unit

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

1 minute to 1 week (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants both with and without hsPDA. They will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation. Those without a hsPDA will be monitored solely around the time of initial echocardiogram. Those with a hsPDA will be monitored around initial echocardiogram and the subsequent echocardiogram after treatment completion.

Description

Inclusion Criteria:

  • preterm infants less than 32 weeks gestation

Exclusion Criteria:

  • infection, congenital heart disease, syndromic anomalies, and perinatal asphyxia.

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
no PDA
These are infants who do not have a patent ductus arteriosus (PDA) as determine by echocardiography
Device: near infrared spectroscopy
Near infrared spectroscopy will be placed on infants both with and without hsPDA
hsPDA
These are infants who have a hemodynamically significant PDA (hsPDA) as determined by echocardiography
Device: near infrared spectroscopy
Near infrared spectroscopy will be placed on infants both with and without hsPDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in NIRS readings
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

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

December 1, 2016

Primary Completion (ACTUAL)

June 30, 2018

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (ESTIMATE)

January 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4585

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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