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

Neonatal Respiratory Distress Syndrome Clinical Trial

Official title: A Randomized, Open, Multinational, Multicentre,2-Part Study In Spontaneously Breathing Preterm Neonates With Mild To Moderate Respiratory Distress Syndrome (RDS) To Investigate The Safety, Tolerability And Efficacy Of Inhaled Nebulised Poractant Alfa (Porcine Surfactant, Curosurf®) In Comparison With Nasal Continuous Positive Airway Pressure (nCPAP) Alone

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The study will be conducted in spontaneously breathing preterm neonates with mild to moderate RDS and will consist of two parts:

Part I, with the objective to assess the safety and tolerability of single ascending doses of nebulised Curosurf® ; Part II, with the objective to compare the efficacy of nebulised Curosurf®, administered at two selected doses from part I, during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life. ;

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Neonatal Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

• NCT number: NCT03235986
• Study type: Interventional
• Source: Chiesi Farmaceutici S.p.A.
• Status: Terminated
• Phase: Phase 2
• Start date: August 28, 2017
• Completion date: May 5, 2020