@article {Jardine51, author = {Luke Jardine and Kei Lui and Helen G Liley and Timothy Schindler and James Fink and Jeanette Asselin and David Durand}, title = {Trial of aerosolised surfactant for preterm infants with respiratory distress syndrome}, volume = {107}, number = {1}, pages = {51--55}, year = {2022}, doi = {10.1136/archdischild-2021-321645}, publisher = {BMJ Publishing Group}, abstract = {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{\textquoteright} Hospital, Brisbane, and Royal Hospital for Women, Sydney, Australia.Patients Infants 26 weeks through 30 weeks gestation who required nCPAP 6{\textendash}8 cmH2O and fraction of inspired oxygen (FiO2) \<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 (FiO2{\texttimes}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.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.Data are available upon reasonable request. Data not included in the article text may be available for subsequent meta-analysis. Please contact the corresponding author for details.}, issn = {1359-2998}, URL = {https://fn.bmj.com/content/107/1/51}, eprint = {https://fn.bmj.com/content/107/1/51.full.pdf}, journal = {Archives of Disease in Childhood - Fetal and Neonatal Edition} }