Status:
RECRUITING
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
Lead Sponsor:
Ferrer Internacional S.A.
Conditions:
Persistent Pulmonary Hypertension of Newborn
Eligibility:
All Genders
Up to 44 years
Brief 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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- None.
Key Trial Info
Start Date :
February 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06499363
Start Date
February 25 2025
End Date
December 31 2027
Last Update
September 3 2025
Active Locations (4)
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1
CHU Lyon (HCL) - Hopital Femme Mère Enfant
Bron, France, 69500
2
Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant
Grenoble, France, 38043
3
CHU Lille - Clinique de Néonatalogie
Lille, France, 59000
4
CHU de Toulouse Hopital des enfants - Réanimation Néonatale
Toulouse, France, 31300