Recruiting
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
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).
ClinicalTrials.gov IDNCT06499363
PhaseNot Applicable
Enrollment60
SponsorFerrer Internacional S.A.
AgeUp to 44 Weeks
SexALL
Conditions studied
Persistent Pulmonary Hypertension of Newborn
About this study
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).
Primary outcomes
- Characteristics of neonates receiving treprostinil in the clinical practice. (From baseline to Day 30 after last dose of treprostinil)
- Treprostinil-specific treatment patterns. (From baseline to Day 30 after last dose of treprostinil)
- Number of participants with treatment-related adverse events to evaluate safety. (From baseline to Day 30 after last dose of treprostinil)
Eligibility information
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 locations
- CHU Lyon (HCL) - Hopital Femme Mère Enfant, Bron, 69500 France
- Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant, Grenoble, 38043 France
- CHU Lille - Clinique de Néonatalogie, Lille, 59000 France
- CHU de Toulouse Hopital des enfants - Réanimation Néonatale, Toulouse, 31300 France
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-13.