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Clinical Trials/NCT05686343
NCT05686343
Recruiting
Not Applicable

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

Ankara University1 site in 1 country70 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patent Ductus Arteriosus After Premature Birth
Sponsor
Ankara University
Enrollment
70
Locations
1
Primary Endpoint
Diameter of PDA
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
July 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Özlem Bayram

Principal Investigator

Ankara University

Eligibility Criteria

Inclusion Criteria

  • Born at less than 32 weeks newborns

Exclusion Criteria

  • Congenital heart disease
  • Syndromic and/or major congenital anomaly

Outcomes

Primary Outcomes

Diameter of PDA

Time Frame: 1 year

Measurement the diameter of ductus in mm/weight using echocardiography

Velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries

Time Frame: 1 year

Measurement velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries using doppler ultrasonography

Velosity of PDA

Time Frame: 1 year

Measurement the velosity of ductus using CW doppler on ecocardiyograpy

Left ventricule expansion

Time Frame: 1 year

Measurement left ventricule end diastolic and end systolic diameter, left atrium/aort ratio on ecocardiography

Study Sites (1)

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