TerminatedPhase 2

Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus

Stopped: very slow enrollment. Only one patient enrolled. Termination by PI

United States1 participantsStarted 2018-12-15

Plain-language summary

The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard treatment strategy of using intravenous ibuprofen alone among preterm infants.

Who can participate

Age range

5 Days – 21 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

. Preterm infant ≤27 6/7
. Written parental consent is obtained
. Infant requires respiratory support
. diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at least two of the following:
. Ductus size ≥ 1.5 mm
. Maximum flow velocity through the ductus ≤ 2 m/s
. Left atrium to aorta ratio ≥ 1.4
. Wide pulse pressure

Exclusion criteria

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

Proportion of Participants With Ductus Arteriosus Closure/Constriction

Timeframe: 24-48 hours after the completion of study intervention

Trial details

NCT IDNCT03701074

SponsorUniversity of South Alabama

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-30

Results submitted2021-04-18

View on ClinicalTrials.gov More Patent Ductus Arteriosus trials