TerminatedPhase 3

Acetaminophen vs Indomethacin in Treating hsPDA

Stopped: Difficulty enrolling patients

United States37 participantsStarted 2016-06

Plain-language summary

The purpose of this study is to see if acetaminophen (Tylenol) is as effective as indomethacin in closing patent ductus arteriosus in premature infants.

Who can participate

Age range

22 Weeks – 32 Weeks

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: * Gestational age at birth 22 weeks to 31 6/7 weeks. * Birth weight ≤ 1500 grams * Day of life ≤ 21 days * ECHO findings: Left-to-right ductal flow AND 2 of the following 3: * Ductal size \> 1.5mm at smallest diameter * Reversal of flow in descending aorta * Left atrial size to aortic root ratio \>1.5 * Platelet count \> 50,000 Exclusion Criteria: * Ductal dependent congenital heart disease * Major congenital anomaly * Life-threatening infection * Urine output \< 1cc/kg/hr in prior 8 hours * Serum creatinine \> 1.8 mg/dL * Hyperbilirubinemia requiring exchange transfusion * Active NEC Stage 2 or 3 using Bell's staging criteria * Active intestinal perforation * Liver dysfunction \[2x upper limit of normal for aspartate aminotransferase(AST) and/or alanine aminotransferase (ALT)\] * Active GI bleeding * Concurrent hydrocortisone use * Known IVH Grade 3 or 4

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

Successful treatment of PDA closure

Timeframe: Follow-up ECHO to assess for closure within 7 days of treatment initiation

Trial details

NCT IDNCT03537144

SponsorUniversity of Tennessee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09

View on ClinicalTrials.gov More Patent Ductus Arteriosus trials

Who can participate

Age range

22 Weeks – 32 Weeks

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.