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NCT Number: NCT06499363

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

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).

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Key information

Conditions

Persistent Pulmonary Hypertension of Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hypertension, Pulmonary Infant, Newborn, Diseases Lung Diseases Persistent Fetal Circulation Syndrome Respiratory Tract Diseases

Age range

Up to 44 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lyon (HCL) - Hopital Femme Mère Enfant, Bron, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Characteristics of neonates receiving treprostinil in the clinical practice.

    Time frame: From baseline to Day 30 after last dose of treprostinil

    Sex (male/female) ; Gestational Age (weeks) ; Birth Weight (g) ; Apgar (1 and 5 min, 0-10) and Time from birth to treprostinil initiation (h)

  2. Treprostinil-specific treatment patterns.

    Time frame: From baseline to Day 30 after last dose of treprostinil

    Prior concomitant treatments, treprostinil route, treprostinil dose(s) (mg/ml) and treprostinil treatment duration (days).

  3. Number of participants with treatment-related adverse events to evaluate safety.

    Time frame: From baseline to Day 30 after last dose of treprostinil

Secondary outcomes

  1. 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

  2. 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).

    Evolution of pre- and post-ductal oxygen saturation (SpO2); oxygen partial pressure (PO2); clinical laboratory parameters and fraction of inspired oxygen (FiO2) at times 0h, 24h, 48h, 72h, Day 7, Day 14, and Day 30 after last dose of treprostinil.

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ferrer MedInfo

CONTACT

[email protected]

609850565

Sponsors and collaborators

Lead sponsor

Ferrer Internacional S.A.

Industry

Registry information

Official study title

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

Acronym: NEPHY

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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