Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Persistent Pulmonary Hypertension of Newborn
- Sponsor
- Ferrer Internacional S.A.
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Characteristics of neonates receiving treprostinil in the clinical practice.
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- Not provided
Outcomes
Primary Outcomes
Characteristics of neonates receiving treprostinil in the clinical practice.
Time Frame: From baseline to Day 30 after last dose of treprostinil
Sex (male/female) ; Gestational Age (weeks) ; Birth Weight (g) ; Apgar (1 and 5 min, 0-10) and Time from birth to treprostinil initiation (h)
Number of participants with treatment-related adverse events to evaluate safety.
Time Frame: From baseline to Day 30 after last dose of treprostinil
Treprostinil-specific treatment patterns.
Time Frame: From baseline to Day 30 after last dose of treprostinil
Prior concomitant treatments, treprostinil route, treprostinil dose(s) (mg/ml) and treprostinil treatment duration (days).
Secondary Outcomes
- Description of neurodevelopmental progress over 2 years after treprostinil initiation through a Global Clinical Impression Scale.(From day 30 after treprostinil treatment to Year 2 after last dose of treprostinil)
- Composite endpoint of absence of complications through Day 14 after the index date.(From baseline to Day 30 after last dose of treprostinil)
- Description of the clinical outcomes from treprostinil start day (i.e., Day 0) to Day 14 and at Day 30 after last dose of treprostinil.(0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil (if applicable).)