Persistent Pulmonary Hypertension of Newborn
Conditions
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).
Interventions
None listed
Sponsors
Ferrer Internacional S.A.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
No minimum to 44 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of neonates receiving treprostinil in the clinical practice. | 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) |
| Treprostinil-specific treatment patterns. | 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). |
| Number of participants with treatment-related adverse events to evaluate safety. | From baseline to Day 30 after last dose of treprostinil | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Evolution of pre- and post-ductal oxygen saturation (SpO2); oxygen partial pressure (PO2); clinical laboratory parameters and fraction of inspired oxygen (FiO2) at times 0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil. |
| 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 | — |
Countries
France
Contacts
Primary ContactFerrer MedInfo
Outcome results
None listed