We evaluate the safety of an aerosolised surfactant, SF-RI 1, administered via nasal continuous positive airway pressure (nCPAP) and a prototype breath synchronisation device (AeroFact), to preterm infants with respiratory distress syndrome (RDS).

open-label, dose-escalation study with historical controls.

Newborn intensive care units at Mater Mothers’ Hospital, Brisbane, and Royal Hospital for Women, Sydney, Australia.

Infants 26 weeks through 30 weeks gestation who required nCPAP 6–8 cmH2O and fraction of inspired oxygen (FiO2) <0.30 at <2 hours of age.

In part 1, infants received a single dose of 216 mg/kg of aerosolised surfactant. In part 2, infants could receive up to four doses of aerosolised surfactant. Three historical control infants were matched for each enrolled infant.