Randomized Trial of Surfactant Therapy via Laryngeal Mask Airway Versus Brief Tracheal Intubation in Neonates Born Preterm

Abstract

Objective: To evaluate the possible noninferiority of surfactant administration via laryngeal mask airway (LMA) vs endotracheal tube (ETT) in avoiding the requirement for mechanical ventilation in preterm neonates with respiratory distress syndrome (RDS).

Study design: This was a randomized controlled trial including infants born at 27 to 36 weeks of gestation, >800 g, diagnosed with RDS and receiving fraction of inspired oxygen 0.30-0.60 via noninvasive respiratory support. Infants were randomized to surfactant via LMA (with atropine premedication) or ETT (InSuRE approach with atropine and remifentanil premedication). Primary outcome was failure of surfactant treatment to prevent the need for mechanical ventilation.

Results: Patients were randomized, 51 to LMA and 42 to the ETT group. Both groups had similar baseline characteristics, with birth weights ranging from 810 to 3560 g. Failure rate was 29% in the ETT group and 20% in the LMA group (P = .311). This difference was due to early failures (within 1 hour), with 12.5% in the ETT group and 2% in the LMA group (P = .044). Surfactant therapy via LMA was non-inferior to administration via ETT; failure risk difference -9.0% (CI -∞ to 5.7%). Efficacy in decreasing fraction of inspired oxygen, number of surfactant doses administered, time to wean off all respiratory support, rates of adverse events, and outcomes including pneumothorax and BPD diagnosis did not differ between groups.

Conclusions: Surfactant therapy via LMA was noninferior to administration via ETT and it decreased early failures, possibly by avoiding adverse effects of premedication, laryngoscopy, and intubation. These characteristics make LMA a desirable conduit for surfactant administration.

Trial registration: ClinicalTrials.gov, NCT02164734.

Keywords: infant; laryngeal mask; newborn; premedication; remifentanil; respiratory distress syndrome; supraglottic airway devices.