Early surfactant for neonates with mild to moderate respiratory distress syndrome:: A multicenter, randomized trial

Objective We studied the efficacy and safety of electively providing surfactant to preterm infants with mild to moderate respiratory distress syndrome (RDS) not requiting mechanical ventilation. Study design A 5-center, randomized clinical trial was performed on 132 infants with RDS, birth weight greater than or equal to1250 grams, gestational age less than or equal to36 weeks, postnatal age 4 to 24 hours, F-IO2 greater than or equal to40% for greater than or equal to1 hour, and no immediate need for intubation. Infants were randomly assigned to intubation, surfactant (Survanta, Ross Laboratories, Columbus, Ohio) administration, and expedited extubation (n = 65) or expectant management (n = 67) with subsequent intubation and surfactant treatment as clinically indicated. The primary outcome was duration of mechanical ventilation. Results infants in the surfactant group had a median duration of mechanical ventilation of 2.2 hours compared with 0.0 hours for control infants, since only 29 of 67 control infants required mechanical ventilation (P = .001). Surfactant-treated infants were less likely to require subsequent mechanical ventilation for worsening respiratory disease (26% vs 43%, relative risk = 0.60; 95% CI, 0.37, 0.99). There were no differences in secondary outcomes (duration of nasal continuous positive airway pressure, oxygen therapy, hospital stay, or adverse outcomes). Conclusions Routine elective intubation for administration of surfactant to preterm infants greater than or equal to1250 grams with mild to moderate RDS is not recommended.