1Department of Pediatrics, University of Minnesota, Minneapolis, MN2Department of Biostatistics, University of Minnesota, Minneapolis, MN3Department of Pediatrics, Children's Minnesota, St. Paul, MN4Department of Pediatrics, Columbia University, New York, NY5Department of Pediatrics, University of California-San Diego, San Diego, CA6Department of Pediatrics, Sharp Mary Birch, San Diego, CA7Department of Pediatrics, Loma Linda University, Loma Linda, CA8Department of Pediatrics, University of Wisconsin-Madison, Madison, WI9Department of Pediatrics, University of Mississippi, Jackson, MS
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ObjectiveTo determine if preterm infants with moderate respiratory distress syndrome on continuous positive airway pressure (CPAP) who received surfactant via a laryngeal mask airway (LMA) would have a decreased rate of intubation and mechanical ventilation compared with those on CPAP who did not receive surfactant.Study designIn this prospective, multicenter, randomized controlled trial, 103 premature infants 280/7-356/7 weeks gestation, ≥1250 g and ≤36 hours old on CPAP requiring fraction of inspired oxygen 0.30-0.40 were assigned to receive surfactant administered through an LMA then placed back on CPAP (LMA group) or maintained on CPAP with no surfactant administered (control group). The primary outcome was treatment failure necessitating intubation and mechanical ventilation in the first 7 days of life.ResultsSurfactant administration through an LMA (n = 50) significantly decreased the rate of intubation and mechanical ventilation compared with controls (n = 53): 38% vs 64%, respectively, OR 0.30 (95% CI 0.13, 0.70), P = .006, number needed to treat: 4). There were no serious adverse events associated with placement of the LMA or surfactant administration.ConclusionsIn premature neonates with moderate respiratory distress syndrome, surfactant administered through an LMA decreased the rate of intubation and mechanical ventilation. This intervention may have significant impact on clinical care in both high and low resource settings.Trial registrationClinicalTrials.gov: NCT01116921.