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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).
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| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of neonates receiving treprostinil in the clinical practice. | Sex (male/female) ; Gestational Age (weeks) ; Birth Weight (g) ; Apgar (1 and 5 min, 0-10) and Time from birth to treprostinil initiation (h) | From baseline to Day 30 after last dose of treprostinil |
| Treprostinil-specific treatment patterns. | Prior concomitant treatments, treprostinil route, treprostinil dose(s) (mg/ml) and treprostinil treatment duration (days). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 60 newborns with PH (of whom at least 40 newborns with persistent pulmonary hypertension of the newborn [PPHN]) are expected to be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ferrer MedInfo | Contact | 609850565 | medinfo@ferrer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lyon (HCL) - Hopital Femme Mère Enfant | Recruiting | Bron | 69500 | France |
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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.
| 0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil (if applicable). |
| 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 |
| Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant | Recruiting | Grenoble | 38043 | France |
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| CHU Lille - Clinique de Néonatalogie | Recruiting | Lille | 59000 | France |
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| CHU de Toulouse Hopital des enfants - Réanimation Néonatale | Recruiting | Toulouse | 31300 | France |
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| ID | Term |
|---|---|
| D010547 | Persistent Fetal Circulation Syndrome |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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