O0694 Oct.3: 3:05pm - Randomized Trial of Surfactant Therapy via Laryngeal Mask Airway vs. Brief Tracheal Intubation

Background: The Intubation-Surfactant-Extubation (INSURE) approach to treatment of respiratory distress syndrome (RDS) involves laryngoscopy and endotracheal tube (ETT) insertion, for which analgesic premedication is recommended. The laryngeal mask airway (LMA) is a potential alternative for surfactant administration while avoiding the need for sedation. A prior randomized trial compared surfactant given via LMA versus ETT using morphine premedication for INSURE, revealing a higher INSURE failure rate. We subsequently adopted remifentanil for INSURE, given its short-lasting sedative effect.

Objective: To compare the efficacy of surfactant administration via LMA vs. ETT (INSURE approach with remifentanil) in avoiding mechanical ventilation requirement in preterm neonates with moderate RDS.

Methods: Prospective, single center randomized control trial including infants born at 27 to 36 weeks gestation, ≥ 800 grams, diagnosed with RDS and on positive pressure non-invasive ventilation with FiO2 0.30-0.60 within the first 48 hours of age. Infants were randomized to receive surfactant via LMA or ETT. Initially, randomization ratio was 1:1; after the planned interim analysis, it was changed to 2:1 ratio LMA:ETT. Both groups received atropine premedication, and the ETT group also received remifentanil 2 µg/kg. Primary outcome was failure of surfactant treatment to prevent need for mechanical ventilation.

Results: 90 patients were randomized, with 50 in the LMA group and 40 in the ETT group. Both groups were similar on baseline characteristics, with birth weight range of 810-3560 grams. Failure rate was 30% in the ETT group and 20% in the LMA group (p = 0.273). This difference was due to early failures (within 1 hour), with 12.5% in the ETT group and 2% in the LMA group (p = 0.047). Late failure rate did not differ between groups. The number of surfactant doses administered per patient, the efficacy of surfactant in decreasing FiO2, and the time to wean off all respiratory support were similar in both groups. The rates of adverse events, including pneumothorax and BPD diagnosis, did not differ between groups

Conclusions: Surfactant therapy via LMA had similar clinical efficacy to ETT administration. The decrease in early failures in the LMA group suggests that its use may avoid adverse effects of premedication, laryngoscopy and intubation, which makes it an desirable approach for surfactant administration.