NCT06499363Recruiting
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 21 May 2024
- Start date
- 25 Feb 2025
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- Ferrer Internacional S.A.
- NCT number
- NCT06499363
What you commit to
- Study type: Observational
- Planned participants: 60
- From 25 Feb 2025 to the primary completion date, 30 Jul 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None.
Who the study is looking for
- 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.
Age in the registry: - to 44 weeks · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Lyon (HCL) - Hopital Femme Mère Enfant Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| CHU Lille - Clinique de Néonatalogie Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU de Toulouse Hopital des enfants - Réanimation Néonatale Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.