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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus After Premature Birth
• Premature Birth

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