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Study questions routine ibuprofen for preemie heart condition

NCT ID NCT07533721

Knowledge-focused Sponsor: Shengjing Hospital 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 541 premature babies with a heart condition called patent ductus arteriosus (PDA). Half received ibuprofen to close the vessel, while the other half got only supportive care like fluids or diuretics. Researchers compared closure rates and complications to see which approach works better for different gestational ages.

What this could mean

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

Active substance
Ibuprofen
What this could lead to
If successful, this could help doctors decide whether to use ibuprofen or simply monitor premature babies with a common heart condition, potentially reducing unnecessary drug exposure.
What could go wrong
This is a retrospective study, not a randomized trial, so results may be influenced by unmeasured factors. The findings may not apply to all hospitals or patient groups.

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.

Participants

541 people

The number who actually took part.

Started

Jun 2020

Finished

Jun 2025

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.

Who is studied

Preterm infants with hsPDA treated at a tertiary NICU in China. The cohort includes 541 infants: 241 received ibuprofen, 300 received expectant management. Gestational age subgroups: \<28 weeks, 28-33 weeks, 33-37 weeks. Both sexes included. No healthy volunteers.

Ages

23 to 37 weeks

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: * \- Preterm infants (gestational age \<37 weeks) with echocardiographically confirmed hemodynamically significant patent ductus arteriosus (hsPDA) * Admitted to the Department of Neonatology, Shengjing Hospital of China Medical University between June 2020 and June 2025 Exclusion Criteria: * \- Major congenital anomalies or chromosomal disorders * Congenital heart disease other than PDA * Contraindications to ibuprofen (e.g., renal failure, necrotizing enterocolitis) * Missing outcome data * Received other PDA pharmacotherapy before study intervention

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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.

Infant, premature Patent ductus arteriosus

Contacts and locations

Locations

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.