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 range44 Weeks

SexALL

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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

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