Trial of aerosolised surfactant for preterm infants with respiratory distress syndrome.

OBJECTIVE

To 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).

DESIGN

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

SETTING

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

PATIENTS

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

INTERVENTIONS

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.

MAIN OUTCOME MEASURES

Treatment failure was defined as Respiratory Severity Score (FiO×cmHO nCPAP) >2.4, nCPAP >8 cmHO, 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.

RESULTS

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 (p=0.10).

CONCLUSION

The AeroFact system can safely deliver aerosolised surfactant to preterm infants with RDS who are on nCPAP.

TRIAL REGISTRATION NUMBER

ACTRN12617001458325.