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NCT05686343 Clinical Trial

Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

Patent Ductus Arteriosus After Premature Birth Clinical Trial

Official title:
Hemodynamically Important PDA in Newborns Under 32 Weeks: Clinical and Echocardiographic Findings and Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05686343
Other study ID # Ankara University-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date July 1, 2023

Study information
Verified date December 2022
Source Ankara University
Contact Özlem Bayram
Phone 05058192105
Email drbayram.ozlem@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To define the characteristics of hemodynamically significant PDA by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal Doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with NIRS in newborns below 32 weeks of age with PDA.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers
Gender All
Age group 1 Minute to 7 Days
Eligibility Inclusion Criteria: - Born at less than 32 weeks newborns Exclusion Criteria: - Congenital heart disease - Syndromic and/or major congenital anomaly

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Echocardiography, Doppler ultrasonography, Near-infrared spectroscopy
Ecocardiography at 1st, 3rd and 7th day of life Doppler US (cranial and renal) at 1st, 3rd and 7th day of life Near-infrared spectroscopy monitoring after birth during first 3-days of life

Locations
Country Name City State
Turkey Özlem Bayram Ankara

Sponsors (1)
Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diameter of PDA Measurement the diameter of ductus in mm/weight using echocardiography 1 year
Primary Velosity of PDA Measurement the velosity of ductus using CW doppler on ecocardiyograpy 1 year
Primary Left ventricule expansion Measurement left ventricule end diastolic and end systolic diameter, left atrium/aort ratio on ecocardiography 1 year
Primary Velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries Measurement velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries using doppler ultrasonography 1 year
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