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Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
NCT06499363 · Ferrer Internacional S.A.
In plain English
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Official title
Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.
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).
Eligibility criteria
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 design
Enrollment target: 60 participants
Age groups: child
Timeline
Starts: 2025-02-25
Estimated completion: 2027-12-31
Last updated: 2025-09-03
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)
Sponsor
Ferrer Internacional S.A. · industry
Contacts & investigators
ContactFerrer MedInfo · contact · medinfo@ferrer.com · 609850565
All locations (4)
CHU Lyon (HCL) - Hopital Femme Mère EnfantRecruiting
Bron, France
Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple EnfantRecruiting
Grenoble, France
CHU Lille - Clinique de NéonatalogieRecruiting
Lille, France
CHU de Toulouse Hopital des enfants - Réanimation NéonataleRecruiting
Toulouse, France