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Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05686343
Enrollment
70
Registered
2023-01-17
Start date
2022-07-01
Completion date
2023-07-01
Last updated
2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus After Premature Birth

Keywords

Cardiology, Newborn, Diseases, Congenital Heart Defects, Patent Ductus Arteriosus

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.

Interventions

DIAGNOSTIC_TESTEchocardiography, 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

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 7 Days

Inclusion criteria

* Born at less than 32 weeks newborns

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Diameter of PDA1 yearMeasurement the diameter of ductus in mm/weight using echocardiography
Velosity of PDA1 yearMeasurement the velosity of ductus using CW doppler on ecocardiyograpy
Left ventricule expansion1 yearMeasurement left ventricule end diastolic and end systolic diameter, left atrium/aort ratio on ecocardiography
Velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries1 yearMeasurement velocity of internal carotid arteries, middle carotid arteries, anterior cerebral arteries and renal arteries using doppler ultrasonography

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzlem Bayram
drbayram.ozlem@gmail.com05058192105

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026