Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

Recruiting

• Conditions: Patent Ductus Arteriosus After Premature Birth

• Registration Number: NCT05686343
• Lead Sponsor: Ankara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-01-13
• Last Update Submitted: 2023-01-13
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-17
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Born at less than 32 weeks newborns

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Özlem Bayram; 🇹🇷 Ankara, Turkey