The AeroFact system can safely deliver aerosolised surfactant to preterm infants with respiratory distress syndrome (RDS) who are on nasal continuous positive airway pressure (nCPAP).

10 infants were enrolled in part 1 and 21 in part 2 and were compared with 93 historical controls.

No safety issues were identified. In part 2, 6 of 21 (29%) AeroFact-treated infants compared with 30 of 63 (48%) control infants met failure criteria.

Kaplan-Meier analysis of patients in part 2 showed a trend towards decreased rate of study failure in the AeroFact-treated infants compared with historical controls.

Treatment failure was defined as Respiratory Severity Score (FiO2×cmH2O nCPAP) >2.4, nCPAP >8 cmH2O, arterial carbon dioxide >65 mm Hg, pH <7.20 or three severe apnoeas within 6 hours during the first 72 hours of life. Other outcomes included tolerance of the AeroFact treatment and complications of prematurity.

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