drugset / Trial / NCT02772081

A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration

NCT02772081

Phase 3 Terminated 33 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study compared 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 who have clinical signs of respiratory distress syndrome (RDS).

Timeline

Start
2021-05-18
Primary completion
2022-08-13
Completion
2022-08-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Poractant alfa Other / unclassified 200 mg/kg Other