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

Recruiting now

Conditions studied: Persistent Pulmonary Hypertension of Newborn

In brief

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).

Key facts

Study ID

NCT06499363

Run by

Ferrer Internacional S.A.

People needed

60

Starts

2025-02-25

Expected to finish

2027-12-31

Last updated by the study team

2025-09-03

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• None.

Where it is running

• CHU Lyon (HCL) - Hopital Femme Mère Enfant — Bron, France (enrolling)
• Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant — Grenoble, France (enrolling)
• CHU Lille - Clinique de Néonatalogie — Lille, France (enrolling)
• CHU de Toulouse Hopital des enfants - Réanimation Néonatale — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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