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

Ferrer Internacional S.A.60 enrolled

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Persistent Pulmonary Hypertension of Newborn

Eligibility

Sex: ALLMax age: 44 Weeks

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

Characteristics of neonates receiving treprostinil in the clinical practice.

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

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

Treprostinil-specific treatment patterns.

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

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 Outcomes

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.

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.

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

Central Contacts

Ferrer MedInfo

CONTACT

609850565 medinfo@ferrer.com

Data from ClinicalTrials.gov

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