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Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

Turkey (Türkiye)70 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range

1 Minute – 7 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Born at less than 32 weeks newborns Exclusion Criteria: * Congenital heart disease * Syndromic and/or major congenital anomaly

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diameter of PDA

Timeframe: 1 year

Velosity of PDA

Timeframe: 1 year

Left ventricule expansion

Timeframe: 1 year

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

Timeframe: 1 year

Trial details

NCT IDNCT05686343

SponsorAnkara University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-01

Contact for this trial

Özlem Bayram

05058192105 drbayram.ozlem@gmail.com

View on ClinicalTrials.gov More Patent Ductus Arteriosus After Premature Birth trials

Who can participate

Age range

1 Minute – 7 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Born at less than 32 weeks newborns Exclusion Criteria: * Congenital heart disease * Syndromic and/or major congenital anomaly