RecruitingNCT06499363
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.
Sponsor
Ferrer Internacional S.A.
Enrollment
60 participants
Start Date
Feb 25, 2025
Study Type
OBSERVATIONAL
Conditions
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
Max Age: 44 Weeks
Inclusion Criteria5
- 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 Criteria1
- None.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06499363