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

Recruitingn/aAges any - 44 WeeksAllFerrer Internacional S.A.
NCT06499363 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

4 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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