Trials Sponsors Conditions Drugs Pricing

Conditions

Persistent Pulmonary Hypertension of Newborn

Outcome Measures

Primary Outcomes (3)

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)
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).
From baseline to Day 30 after last dose of treprostinil
Number of participants with treatment-related adverse events to evaluate safety.
From baseline to Day 30 after last dose of treprostinil

Secondary Outcomes (3)

Composite endpoint of absence of complications through Day 14 after the index date.
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.
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.
From day 30 after treprostinil treatment to Year 2 after last dose of treprostinil

Eligibility Criteria

AgeUp to 44 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

Approximately 60 newborns with PH (of whom at least 40 newborns with persistent pulmonary hypertension of the newborn \[PPHN\]) are expected to be included.

You may qualify if:

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.

Sponsors & Collaborators

Ferrer Internacional S.A.
Industrylead

Study Sites (4)

CHU Lyon (HCL) - Hopital Femme Mère Enfant

Bron, 69500, France

RECRUITING

Marine Butin, Medical DoctorCONTACT+33 (0)4 27 85 52 84 marine.butin@chu-lyon.fr

Marine Butin, Medical DoctorPRINCIPAL INVESTIGATOR

Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant

Grenoble, 38043, France

RECRUITING

Amélie Desrumaux, Medical Doctor

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ferrer MedInfo

CONTACT

609850565 medinfo@ferrer.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

July 12, 2024

Study Start

February 25, 2025

Actual (reported)

Primary Completion

July 30, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations