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Can a common painkiller given in the first 12 hours protect premature Babies' brains?

NCT ID NCT01630278

Prevention Sponsor: Nantes University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Very premature infants born before 28 weeks often have a blood vessel near the heart, called the patent ductus arteriosus, that stays open when it should close. A large opening can strain the heart and may affect brain development. In this trial, researchers use an early echocardiogram to find infants with a large ductus and give them either ibuprofen or a placebo within 12 hours of birth. They follow the infants with repeated heart and brain ultrasounds and check at age 2 whether the children survived without cerebral palsy.

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 early ibuprofen treatment works, it could become a standard way to protect the brains and long-term development of very premature infants born with a large patent ductus arteriosus.
What could go wrong
This is a Phase 3 trial, so the approach is still being tested. Ibuprofen can affect kidney function and bleeding risk in fragile premature infants, and closing the duct may not improve neurodevelopment if other factors drive brain injury.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

363 people

The number who actually took part.

Started

Mar 2012

Finished

Jun 2019

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

Up to 28 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: * Gestational less than 28 weeks * Postnatal age less than 12 hours

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Conditions

The condition(s) this trial relates to.

patent ductus arteriosus Premature Birth

As listed by the trial registrant

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

Patent ductus arteriosus

Contacts and locations

Locations

  • University Hopsital

    Angers, France

  • University Hopsital

    Bordeaux, France

  • University Hospital

    Créteil, France

  • University Hospital

    Grenoble, France

  • University Hospital

    Lille, France

  • University Hospital

    Marseille, France

  • University Hospital

    Nantes, France

  • University Hospital

    Rennes, France

  • University Hospital

    Tours, France

  • University Hospital (AP-HP Groupe hospitalier)

    Paris, France

  • Univesity Hospital

    Montpellier, France

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