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 < .001) with no statistically significant differences between groups. Rescue surfactant use [19 (33.9%) vs 17 (29.8%)], BPD [31 (55.4%) and 32 (56.1%)], and mortality at Day 28 [4 (7.1%) and 3 (5.3%)] were similar in the CHF5633 and PA groups, respectively. In 2 (3.4%) and 1 (1.7%) neonates, adverse drug reactions were reported in CHF5633 and PA groups, respectively. No immunogenicity was detected.