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Could a common painkiller help preterm Babies' hearts?

NCT ID NCT04459117

Disease control Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving acetaminophen (a common pain and fever medicine) to extremely preterm babies within the first 12 hours after birth can help close a blood vessel in the heart that normally closes on its own. The trial involved 804 babies born between 23 and 28 weeks of pregnancy across Europe. Researchers checked if the medicine improved survival without severe health problems like lung, gut, or brain damage.

What this could mean

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

Active substance
acetaminophen
What this could lead to
If it works, this could offer a safer way to treat a common heart problem in preterm infants, potentially reducing severe lung, gut, or brain complications.
What could go wrong
This is an early-to-mid-stage trial, so results may not confirm benefit. Acetaminophen may not close the duct effectively in all babies, and side effects like liver strain are possible.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

804 people

The number who actually took part.

Started

Oct 2020

Finished

Jun 2024

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

23 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: * Birth between 23-26 W for Phase II, between 23-28 W for Phase III * Post natal age \< 12 hours * Parental or Legal Authority Consent * Parents with a social security or health insurance (if applicable according to the local regulation) Exclusion Criteria: * Birth defect / Congenital anomaly * Twin-to-twin transfusion syndrome not cured * Suspicion of pulmonary hypoplasia * Suspicion of hepatic impairment (hemorrhagic syndrome and/or severe hypoglycemia) * Clinical instability that can lead to rapid death * Impossibility to start treatment before 12 hours of life * Parents placed under judicial protection * Participation in other clinical trial using acetaminophen during the first 5 days of life, indomethacin or ibuprofen during the first 3 days of life or using rescue treatment of PDA not recommended in the TREOCAPA trial

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Conditions

The condition(s) this trial relates to.

paracetamol poisoning patent ductus arteriosus

As listed by the trial registrant

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

Acetaminophen Extreme prematurity Patency of the ductus arteriosus

Contacts and locations

Locations

  • Azienda Ospedaliero - Universitaria delle Marche

    Ancona, 60126, Italy

  • Bács Kiskun COUNTY HOSPITAL

    Kecskemét, H6000, Hungary

  • CENTRE hospitalier intercommunal de Creteil

    Paris, France

  • CHRU de Tours

    Tours, France

  • CHU Angers

    Angers, France

  • CHU Nantes, Hopital mére Enfant

    Nantes, France

  • CHU Rennes, Hopital Sud

    Rennes, France

  • CHU Strasbourg, Hôpital de Hautepierre

    Strasbourg, France

  • Centre Hospitalier Universitaire de Liège

    Liège, Belgium

  • Centre Hospitalo-Universitaire de Toulouse

    Toulouse, 31059, France

  • Centro Hospitalar Universitário Lisboa Norte, EPE -Hospital Santa Maria

    Lisbon, Portugal

  • Centro Hospitalar e Universitário do Porto, EPE - Centro Materno Infantil do Norte

    Porto, Portugal

  • Cork University Hospital

    Cork, T12 DC4A, Ireland

  • East Tallinn Central Hospital

    Tallinn, Estonia

  • Helsinki University Hospital, Department of Children and Adolecents, Neonatology

    Helsinki, Finland

  • Hopital Cochin, Service de Médecine et Réanimation néonatales de Port-Royal

    Paris, France

  • Hopital Jeanne de Flandre

    Lille, 59037, France

  • Hopital Robert Debré, Néonatologie

    Paris, France

  • Hopital Universitaire de Geneve (HUG) - Hopital des enfants

    Geneva, Switzerland

  • Hospice civils de Lyon, Hopital Femme Enfant

    Lyon, France

  • Hôpital Arnaud de Villeneuve, Département de Pédiatrie Néonatale et Réanimation Pédiatrique

    Montpellier, France

  • Hôpital Croix-Rousse

    Lyon, 69317, France

  • Hôpital Marseille Nord

    Marseille, 13015, France

  • Hôpital Necker - Enfants malades

    Paris, 75015, France

  • Hôpital de la conception

    Marseille, France

  • Karolinska University Hospital

    Solna, 171 64, Sweden

  • Kuopio University Hospital, Department of Pediatrics

    Kuopio, Finland

  • Oslo University Hospital

    Oslo, 0424, Norway

  • Oulu University Hospital, Department of Pediatrics

    Oulu, Finland

  • Tallinn Children's Hospital

    Tallinn, Estonia

  • Tampere University Hospital, Department of Pediatrics

    Tampere, Finland

  • Tartu University Hospital, Neonatal and Paediatric Intensive Care Unit

    Tartu, Estonia

  • The Juliane Marie Centre, Rigshospitalet, Copenhagen University hospital

    Copenhagen, 2100, Denmark

  • Turku University Hospital, Department of Peadiatrics

    Turku, Finland

  • University Children's Hospital Lausanne

    Lausanne, Switzerland

  • University Hospital of Zürich

    Zurich, Switzerland

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