Synthetic Surfactant CHF5633 compared with Poractant Alfa in the Treatment of Neonatal Respiratory Distress Syndrome: A Multicenter, Double Blind, Randomized, Controlled Clinical Trial.

Objective To compare efficacy and safety of a new synthetic surfactant, CHF5633, enriched with surfactant proteins, SP-B and SP-C peptide analogues, with porcine surfactant, poractant alfa for the treatment of respiratory distress syndrome (RDS) in preterm infants. Study design Preterm neonates on respiratory support requiring fraction of inspired oxygen (FiO2) ≥0.30 from 240/7 to 266/7 weeks and FiO2 ≥0.35 from 270/7 to 296/7 weeks gestation to maintain 88-95% oxygen saturation were randomized to receive 200 mg/kg of CHF5633 or PA. If necessary, redosing was given at 100 mg/kg. Efficacy endpoints were oxygen requirement [FiO2, Respiratory Severity Score (RSS) (FiO2 x mean airway pressure)] in the first 24 h, 7 and 28 days, discharge home and/or 36-week postmenstrual age, mortality and bronchopulmonary dysplasia (BPD) at 28 days and 36-week PMA. Adverse events and immunogenicity were monitored for safety. Results Of the 123 randomized neonates, 113 were treated (56 and 57 in CHF5633 and PA groups, respectively). In both arms FiO2 and RSS decreased from baseline at all timepoints (P Conclusion Treatment with CHF5633 showed similar efficacy and safety as PA in preterm neonates with moderate to severe RDS.