Treprostinil for newborns with persistent pulmonary hypertension
Official title: Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.
Run by Ferrer Internacional S.A. · NCT06499363 · Data updated 2026-11-12
This observational project will see if treprostinil used in newborns with persistent pulmonary hypertension appears safe and helpful when used in routine care in French hospitals.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 44 Weeks |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Ferrer Internacional S.A. Industry-sponsored |
| Locations | 4 sites (Bron and 3 other locations) |
| Status | Recruiting |
| Started | February 25, 2025 |
| Main results expected | July 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT06499363 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Newborn infants (up to 44 weeks after conception) with pulmonary hypertension or suspected PH who received at least one IV or SC dose of treprostinil within five years and whose parent or legal representative consents, and who are affiliated with French social security, are ideal candidates.
✕Probably not a fit
Infants who were never treated with treprostinil, treated outside the five-year window, not affiliated with French social security, or lacking consent will not be included and therefore will not directly benefit from this dataset.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a non-interventional, observational registry collecting real-world clinical data on newborns up to 44 weeks post-conception who received at least one IV or SC dose of treprostinil within the five years before data collection. Clinical sites will extract dosing, route, timing, baseline status, adverse events, and short-term outcomes from medical records at participating French tertiary neonatal centers. Parents or legal representatives provide consent for inclusion and no changes to clinical care are required by the protocol. The dataset will be analyzed descriptively to characterize utilization patterns, safety signals, and clinical outcomes in this population.
Why it matters
Potential benefit: If successful, the study could clarify real-world safety and outcome patterns for treprostinil in PPHN and help clinicians make better-informed treatment decisions.
How similar studies have gone: Existing evidence for treprostinil in PPHN is limited largely to case reports and small series, so randomized or large-scale evidence is lacking and this real-world dataset is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
CHU Lyon (HCL) - Hopital Femme Mère Enfant
Bron, France Recruiting -
Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant
Grenoble, France Recruiting -
CHU Lille - Clinique de Néonatalogie
Lille, France Recruiting -
CHU de Toulouse Hopital des enfants - Réanimation Néonatale
Toulouse, France Recruiting
Study contacts
- Study coordinator: Ferrer MedInfo
- Email: medinfo@ferrer.com
- Phone: 609850565
Similar studies
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-
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.