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).
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.
None.
Approximately 60 newborns with PH (of whom at least 40 newborns with persistent pulmonary hypertension of the newborn \[PPHN\]) are expected to be included.
Cohort
Other
Not listed
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)
Treprostinil-specific treatment patterns.
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.
Composite endpoint of absence of complications through Day 14 after the index date.
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.
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.
Click on the lead sponsor to view all of their trials.
