Actively Recruiting
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
Led by Ferrer Internacional S.A. · Updated on 2025-09-03
60
Participants Needed
4
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
CHU Lyon (HCL) - Hopital Femme Mère Enfant
Bron, France, 69500
Actively Recruiting
2
Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant
Grenoble, France, 38043
Actively Recruiting
3
CHU Lille - Clinique de Néonatalogie
Lille, France, 59000
Actively Recruiting
4
CHU de Toulouse Hopital des enfants - Réanimation Néonatale
Toulouse, France, 31300
Actively Recruiting
Research Team
F
Ferrer MedInfo
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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