Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
Recruiting · NCT06499363 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ferrer Internacional S.A.
View the official record on ClinicalTrials.gov →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).
Who can take part
Age range
Up to 44 Weeks
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
- None.
Where it is running
4 locations listed.
- CHU Lyon (HCL) - Hopital Femme Mère Enfant - Bron, France
- Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant - Grenoble, France
- CHU Lille - Clinique de Néonatalogie - Lille, France
- CHU de Toulouse Hopital des enfants - Réanimation Néonatale - Toulouse, France