Overview

A Study in Preterm Neonates With RDS to Compare CUROSURF® Administration Through LISA and Conventional Administration

Status:
Recruiting
Trial end date:
2025-09-30
Target enrollment:
Participant gender:
Summary
This study will compare the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA) using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP) with an approved conventional surfactant administration during invasive ventilation followed by rapid extubation in terms of short term and mid-term safety and efficacy in spontaneously breathing preterm neonates with clinical signs of respiratory distress syndrome (RDS).
Phase:
Phase 3
Details
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Collaborator:
Quintiles, Inc.
Treatments:
Poractant alfa