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NCT03026192 Clinical Trial

Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure

Patent Ductus Arteriosus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03026192
Other study ID # 4585
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 2016
Est. completion date June 30, 2018

Study information
Verified date January 2019
Source Albany Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 1 Week
Eligibility Inclusion Criteria:

- preterm infants less than 32 weeks gestation

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• near infrared spectroscopy
Near infrared spectroscopy will be placed on infants both with and without hsPDA

Locations
Country Name City State
United States Albany Medical Center Neonatal Intesive Care Unit Albany New York

Sponsors (1)
Lead Sponsor Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in NIRS readings 3 days
See also
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Completed NCT03277768 - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.