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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. ;


Study Design


Related Conditions & MeSH terms


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

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