RecruitingNot Applicable

Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness

France60 participantsStarted 2025-02-25

Plain-language summary

This observational study will seek to describe the uses and safety and efficacy outcomes of treprostinil in clinical practice in patients with persistent pulmonary hypertension (PPHN).

Who can participate

Age range

44 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Aged up to 44 weeks after conception at treprostinil initiation.
. Pulmonary hypertension (PH) or suspicion of PH at the moment of treprostinil initiation.
. Parent(s) or legally authorized representative(s) provides non-opposition consent for the patient participation in the study.
. Newborn infants affiliated to French social security.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Characteristics of neonates receiving treprostinil in the clinical practice.

Timeframe: From baseline to Day 30 after last dose of treprostinil

Treprostinil-specific treatment patterns.

Timeframe: From baseline to Day 30 after last dose of treprostinil

Number of participants with treatment-related adverse events to evaluate safety.

Timeframe: From baseline to Day 30 after last dose of treprostinil

Trial details

NCT IDNCT06499363

SponsorFerrer Internacional S.A.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-07-30

Contact for this trial

Ferrer MedInfo

609850565 medinfo@ferrer.com

View on ClinicalTrials.gov More Persistent Pulmonary Hypertension of Newborn trials

Who can participate

Age range

44 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Aged up to 44 weeks after conception at treprostinil initiation.
. Pulmonary hypertension (PH) or suspicion of PH at the moment of treprostinil initiation.
. Parent(s) or legally authorized representative(s) provides non-opposition consent for the patient participation in the study.
. Newborn infants affiliated to French social security.

What they're measuring

Characteristics of neonates receiving treprostinil in the clinical practice.

Timeframe: From baseline to Day 30 after last dose of treprostinil

Treprostinil-specific treatment patterns.

Timeframe: From baseline to Day 30 after last dose of treprostinil

Number of participants with treatment-related adverse events to evaluate safety.

Timeframe: From baseline to Day 30 after last dose of treprostinil