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New study tracks treprostinil use in newborns with lung condition

NCT ID NCT06499363

Knowledge-focused Sponsor: Ferrer Internacional S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This observational study will follow 60 newborns with persistent pulmonary hypertension (PPHN) who receive treprostinil as part of their routine care. Researchers will collect data on how the drug is used, its safety, and its effectiveness in real-world hospital settings. The goal is to better understand treatment patterns and outcomes for these fragile infants.

What this could mean

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

Active substance
treprostinil
What this could lead to
If this study succeeds, it could provide valuable information on how treprostinil is used in real-world practice for newborns with pulmonary hypertension, potentially guiding better treatment decisions.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. The small size (60 participants) and lack of a comparison group limit the strength of conclusions.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Approximately 60 newborns with PH (of whom at least 40 newborns with persistent pulmonary hypertension of the newborn \[PPHN\]) are expected to be included.

Ages

Up to 44 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: 1. Newborn infants who received at least one dose of IV or SC treprostinil as per clinical practice within 5 years from the moment of data collection. 2. Aged up to 44 weeks after conception at treprostinil initiation. 3. Pulmonary hypertension (PH) or suspicion of PH at the moment of treprostinil initiation. 4. Parent(s) or legally authorized representative(s) provides non-opposition consent for the patient participation in the study. 5. Newborn infants affiliated to French social security. Exclusion Criteria: * None.

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Conditions

The condition(s) this trial relates to.

persistent fetal circulation syndrome

As listed by the trial registrant

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

Persistent pulmonary hypertension of newborn

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Lille - Clinique de Néonatalogie

    RECRUITING

    Lille, 59000, France

  • CHU Lyon (HCL) - Hopital Femme Mère Enfant

    RECRUITING

    Bron, 69500, France

  • CHU de Toulouse Hopital des enfants - Réanimation Néonatale

    RECRUITING

    Toulouse, 31300, France

  • Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant

    RECRUITING

    Grenoble, 38043, France