A DOUBLE BLIND, RANDOMIZED, CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF SYNTHETIC SURFACTANT (CHF 5633) IN COMPARISON TO PORCINE SURFACTANT (PORACTANT ALFA, CUROSURF®) IN THE TREATMENT OF PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME

Trial Profile

A DOUBLE BLIND, RANDOMIZED, CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF SYNTHETIC SURFACTANT (CHF 5633) IN COMPARISON TO PORCINE SURFACTANT (PORACTANT ALFA, CUROSURF®) IN THE TREATMENT OF PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME

Recruiting
Phase of Trial: Phase II

Latest Information Update: 18 Jan 2017

At a glance

  • Drugs CHF 5633 (Primary) ; Poractant alfa
  • Indications Neonatal respiratory distress syndrome
  • Focus Therapeutic Use
  • Sponsors Chiesi Farmaceutici
  • Most Recent Events

    • 12 Jan 2017 Planned End Date changed from 1 Jan 2019 to 1 May 2020.
    • 12 Jan 2017 Planned primary completion date changed from 1 Jan 2017 to 1 Feb 2018.
    • 04 May 2016 Status changed from not yet recruiting to recruiting.
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