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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

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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: Discontinued
Phase of Trial: Phase II

Latest Information Update: 11 Mar 2022

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At a glance

  • Drugs Poractant alfa (Primary)
  • Indications Respiratory distress syndrome
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Chiesi Farmaceutici

    • Most Recent Events

    • 04 Mar 2022 Primary endpoint (Percentage of neonates with respiratory failure) has not been met according to the results published in the Journal of Pediatrics
    • 04 Mar 2022 Results published in the Journal of Pediatrics
    • 07 Jun 2020 This trial is discontinued in Hungary, UK and France (Global End Date: 05 May 2020), according to European Clinical Trials Database record.

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