Clinical Trials

Title   [839470-3] A MultiCenter, Double Blind, Randomized, Single Dose, Active-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
Description   A multicenter, double blind, randomized, single dose, active-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. Main objectives of this study are to investigate the short term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf┬«) in terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of prematurity.
IRB Number   15-362
Treatment   Respiratory Distress Syndrome
Status   Active
Principal Name   Fabien Eyal, M.D.

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