Nebulised surfactant to reduce severity of respiratory distress: a blinded, parallel, randomised controlled trial

OBJECTIVE: To evaluate if nebulised surfactant reduces intubation requirement in preterm infants with respiratory distress treated with nasal continuous positive airway pressure (nCPAP). DESIGN: Double blind, parallel, stratified, randomised control trial. SETTING: Sole tertiary neonatal unit in West Australia. PATIENTS: weeks' gestational age, GA) less than 4 hours of age requiring 22%-30% supplemental oxygen, with informed parental written consent. INTERVENTIONS: weeks' GA) to bubble nCPAP or bubble nCPAP and nebulised surfactant (200 mg/kg: poractant alfa) using a customised vibrating membrane nebuliser (eFlow neonatal). Surfactant nebulisation (100 mg/kg) was repeated after 12 hours for persistent supplemental oxygen requirement. MAIN OUTCOME MEASURES: The primary outcomes were requirement for intubation and duration of mechanical ventilation at 72 hours. Data analysis followed the intention-to-treat principle. RESULTS: weeks' GA stratum. The median (range) duration of ventilation in the first 72 hours was not different between the intervention (0 (0-62) hours) and control (9 (0-64) hours; p=0.220) groups. There were no major adverse events. CONCLUSIONS: weeks' GA with mild respiratory distress syndrome. Confirmation requires further adequately powered studies. TRIAL REGISTRATION NUMBER: ACTRN12610000857000.