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Abandoned study: can a common painkiller help close a tiny heart vessel in preemies?

NCT ID NCT03701074

Disease control Sponsor: University of South Alabama Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether adding acetaminophen to standard ibuprofen treatment could better close a blood vessel (ductus arteriosus) that stays open too long in very premature infants. The trial was planned for preterm babies born at or before 27 weeks and 6 days who needed breathing support. However, the study was stopped early after enrolling only one participant, so no meaningful conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acetaminophen and ibuprofen
What this could lead to
If it worked, this could point toward a more effective way to close a common heart vessel issue in premature babies, potentially reducing complications.
What could go wrong
The trial was terminated very early with only one participant, so we have almost no data. It is unclear if the combination is safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1 person

The number who actually took part.

Started

Dec 2018

Finished

Dec 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 21 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Preterm infant ≤27 6/7 2. Written parental consent is obtained 3. Infant requires respiratory support 4. diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at least two of the following: 1. Ductus size ≥ 1.5 mm 2. Maximum flow velocity through the ductus ≤ 2 m/s 3. Left atrium to aorta ratio ≥ 1.4 4. Wide pulse pressure 5. B-type natriuretic peptide (BNP) 5. Attending neonatologist made decision to treat patent ductus arteriosus Exclusion Criteria: 1. No parental consent 2. Infants \> 21days of postnatal age 3. Congenital anomalies such as cardiac or multiple anomalies 4. Infection (e.g., septicemia, pneumonia) 5. Bleeding disorder or platelet count\< 50,000/ml 6. Acute kidney injury (AKI)defined as oliguria (urine output\< 0.5 ml/kg/hr for 16hrs) and/or serum creatinine \> 1.5 mg/dl 7. Elevated liver enzymes (\>2 fold from upper normal limits) 8. Pulmonary hypertension or right to left shunt through the ductus arteriosus 9. Diagnosis of necrotizing enterocolitis 10. Unable to tolerate oral medications at the time of enrollment.

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia patent ductus arteriosus Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchopulmonary dysplasia Patent ductus arteriosus Preterm infant

Contacts and locations

Locations

  • University of South Alabama

    Mobile, Alabama, 36607, United States

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