1. In a randomized controlled trial, laryngeal mask airway (LMA) surfactant administration was associated with lower rates of early failure and less surfactant reflux than endotracheal tube (ETT) surfactant administration.
2. LMA and ETT surfactant administration did not differ in terms of adverse events during treatment, clinical outcomes, or risk of BPD or mortality.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Early surfactant therapy improves pulmonary outcomes and mortality for infants with respiratory distress syndrome (RDS). However, surfactant therapy has traditionally required intubation and mechanical ventilation which can itself lead to lung injury. As a result, there are ongoing efforts to pursue non-invasive methods to administer surfactant, such as through a LMA, to avoid intubation. The objective of this randomized controlled study of 93 premature infants was to evaluate if LMA was a suitable alternative route of administration compared to an endotracheal tube. Researchers found that there were no differences between ETT and LMA groups in terms of clinical outcomes including adverse events during surfactant administration, unrelated intubations following treatment, number of surfactant doses, pneumothorax, pulmonary hemorrhage, BPD, and death. In addition, the LMA group had a lower risk of early failure (within 1 hour) following surfactant administration compared to the ETT group. One major limitation was lack of blinding to treatment which could influence clinical decisions such as surfactant doses, intubation/extubation, respiratory management and settings, and use of premedication. This study provides evidence that LMA administration of surfactant to infants with RDS is non-inferior to ETT administration. Future studies are required to study the use of LMAs for surfactant administration in other cohorts to provide external validation.
Click here to read the article in the Journal of Pediatrics
In-Depth [randomized controlled trial]: This was a single center (Albany Medical Center NICU) randomized controlled trial conducted from Nov 2014 to April 2020. This study enrolled premature infants between 27 and 37 weeks gestational age with clinical evidence of RDS requiring non-invasive respiratory support to maintain a normal oxygen saturation. No blinding occurred following randomization. Primary outcomes included failure of surfactant therapy, requiring standard therapy with ETT and mechanical ventilation. Failure was subdivided into early (within 1 hour) and late failure. Failure was defined as 2+ doses of surfactant therapy, FiO2 >0.60 to maintain target oxygen saturations, or a second dose of surfactant within 8 hours of initial dose. Secondary outcomes included number of surfactant doses, days on respiratory support and oxygen, pneumothorax, adverse events, and mortality. In the study timeframe, 329 patients were eligible for the study, 93 were randomized with 42 allocated to ETT group and 51 to the LMA group. LMA group had lower rates of surfactant reflux during administration (0% vs 9.7%, p=0.006) and lower rates of early failure (2% vs 12%, p=0.044), when compared to ETT group. There were no statistical differences between LMA or ETT in any other primary or secondary outcomes.
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