Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.
Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 10 months
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
France
CHU Lyon (HCL) - Hopital Femme Mère Enfant
RECRUITING
Bron
Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant
RECRUITING
Grenoble
CHU Lille - Clinique de Néonatalogie
RECRUITING
Lille
CHU de Toulouse Hopital des enfants - Réanimation Néonatale
RECRUITING
Toulouse
Contact Information
Primary
Ferrer MedInfo
medinfo@ferrer.com
609850565
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Related Therapeutic Areas
Sponsors
Leads: Ferrer Internacional S.A.