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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 Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness

Recruiting
44 years and younger
All
Phase N/A

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Overview

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

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.

Study details
    Persistent Pulmonary Hypertension of Newborn

NCT06499363

Ferrer Internacional S.A.

15 October 2025

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