RecruitingNCT06499363

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

Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.


Sponsor

Ferrer Internacional S.A.

Enrollment

60 participants

Start Date

Feb 25, 2025

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Max Age: 44 Weeks

Plain Language Summary

Simplified for easier understanding

This observational study is collecting real-world data on how treprostinil (a drug used to treat high blood pressure in the lungs) is used in newborns with pulmonary hypertension — a serious condition where blood pressure in the lung vessels is dangerously high. **You may be eligible if...** - Your baby received at least one dose of IV or subcutaneous treprostinil in clinical practice within the past 5 years - Your baby was up to 44 weeks gestational age (counting from conception) when treprostinil was started - Your baby had pulmonary hypertension or suspected pulmonary hypertension at the time of treatment - Your baby is enrolled in French social security - Parent(s) or legal guardian(s) have provided consent **You may NOT be eligible if...** - There are no exclusion criteria listed for this study — all eligible newborns may be considered Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(4)

CHU Lyon (HCL) - Hopital Femme Mère Enfant

Bron, France

Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant

Grenoble, France

CHU Lille - Clinique de Néonatalogie

Lille, France

CHU de Toulouse Hopital des enfants - Réanimation Néonatale

Toulouse, France

View Full Details on ClinicalTrials.gov

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NCT06499363


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