Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness
NCT ID: NCT06499363
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2025-02-25
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
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
44 Weeks
ALL
No
Sponsors
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Ferrer Internacional S.A.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FREM-NIS-2301
Identifier Type: -
Identifier Source: org_study_id
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