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

Ferrer

Status: Enrolling

Conditions: Persistent Pulmonary Hypertension of Newborn

Study type: Observational

Funder types: Industry

Identifiers

NCT06499363

FREM-NIS-2301

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: Under 44 weeks old

Volunteers: No Healthy Volunteers

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.