drugset / Trial / NCT03235986

A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)

NCT03235986

Phase 2 Terminated 166 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP.

Timeline

Start
2017-08-28
Primary completion
2020-05-05
Completion
2020-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Poractant alfa Other / unclassified 200 mg/kg Inhaled
Subject Poractant alfa Other / unclassified 400 mg/kg Inhaled