Randomized trial of laryngeal mask airway versus endotracheal intubation for surfactant delivery.

Abstract

To compare the effectiveness of surfactant delivery via endotracheal tube (ETT) using an intubation-surfactant-rapid extubation approach with premedication) vs laryngeal mask airway (LMA) in preventing the need for mechanical ventilation in preterm neonates with moderate respiratory distress syndrome (RDS). Moderately preterm infants diagnosed with RDS, receiving nasal continuous positive airway pressure with FiO2 0.30 to 0.60, were randomized to two groups at age 3 to 48 h. Those in the ETT group were intubated following premedication with atropine and morphine, whereas the LMA group received only atropine. Both groups received calfactant before a planned reinstitution of nasal continuous positive airway pressure, and had equivalent pre-specified criteria for subsequent mechanical ventilation and surfactant retreatment. The primary outcome was failure of surfactant treatment strategy to avoid mechanical ventilation; we differentiated early from late failures to assess the contribution of potential mechanisms such as respiratory depression versus less-effective surfactant delivery. Secondary outcomes addressed efficacy and safety end points. Sixty-one patients were randomized, one excluded and 30 analyzed in each group, with similar baseline characteristics. Failure rate was 77% in the ETT group and 30% in the LMA group (P<0.001). The difference was related to early failure, as late failure rates did not differ between groups. FiO2 decrease after surfactant and rates of adverse events were similar between groups. Surfactant therapy through an LMA decreases the proportion of newborns with moderate RDS who require mechanical ventilation, when compared with a standard endotracheal intubation procedure with sedation. The efficacy of surfactant in decreasing RDS severity appears similar with both methods. Morphine premedication likely contributed to early post-surfactant failures.