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Recruiting NCT06499363

Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness

— Observational Persistent Pulmonary Hypertension of Newborn

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Persistent Pulmonary Hypertension of Newborn. Basic parameters: up to 44 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Treprostinil in Newborns With Pulmonary Hypertension; a Noninterventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness.

Overview

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).

Primary outcome measures

  • Characteristics of neonates receiving treprostinil in the clinical practice. [Time frame: From baseline to Day 30 after last dose of treprostinil]
  • Treprostinil-specific treatment patterns. [Time frame: From baseline to Day 30 after last dose of treprostinil]
  • Number of participants with treatment-related adverse events to evaluate safety. [Time frame: From baseline to Day 30 after last dose of treprostinil]
Secondary outcome measures (3)
  • Composite endpoint of absence of complications through Day 14 after the index date. [Time frame: From baseline to Day 30 after last dose of treprostinil]
  • 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. [Time frame: 0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil (if applicable).]
  • Description of neurodevelopmental progress over 2 years after treprostinil initiation through a Global Clinical Impression Scale. [Time frame: From day 30 after treprostinil treatment to Year 2 after last dose of treprostinil]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 4 centers
  • CHU Lyon (HCL) - Hopital Femme Mère Enfant — Bron
  • Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant — Grenoble
  • CHU Lille - Clinique de Néonatalogie — Lille
  • CHU de Toulouse Hopital des enfants - Réanimation Néonatale — Toulouse

Identifiers

NCT: NCT06499363 · FREM-NIS-2301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗