NCT03235986

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 28 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neonatal Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)	Single ascending doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part I)
DRUG	nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)	Two doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part II)
OTHER	nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)	Nasal continuous positive airway pressure alone
OTHER	nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)	nasal continuous positive airway pressure alone

Timeline

• Start date: 2017-08-28
• Primary completion: 2020-05-05
• Completion: 2020-05-05
• First posted: 2017-08-01
• Last updated: 2022-03-31

Locations

1 site across 1 country: Italy