Importance: The benefits of surfactant administration via a thin catheter minimally invasive surfactant therapy [MIST] in preterm infants with respiratory distress syndrome are uncertain. Objective: To examine the effect of selective application of MIST at a low fraction of inspired oxygen threshold on survival without bronchopulmonary dysplasia BPD. Design, setting, and participants: Randomized clinical trial including preterm infants with a gestational age of 25 to 28 weeks who were supported with continuous positive airway pressure CPAP and required a fraction of inspired oxygen of 0.
The trial was conducted at 33 tertiary-level neonatal intensive care units around the world, with blinding of the clinicians and outcome assessors. Enrollment took place between December 16, , and March 26, ; follow-up was completed on December 2, Main outcomes and measures: The primary outcome was the composite of death or physiological BPD assessed at 36 weeks' postmenstrual age.
The components of the primary outcome death prior to 36 weeks' postmenstrual age and BPD at 36 weeks' postmenstrual age also were considered separately. Results: Among the infants randomized median gestational age, Death or BPD occurred in infants Incidence of death before 36 weeks' postmenstrual age did not differ significantly between groups 24 [ Serious adverse events occurred in Conclusions and relevance: Among preterm infants with respiratory distress syndrome supported with CPAP, minimally invasive surfactant therapy compared with sham control treatment did not significantly reduce the incidence of the composite outcome of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age.
Trial registration: anzctr. Abstract Importance: The benefits of surfactant administration via a thin catheter minimally invasive surfactant therapy [MIST] in preterm infants with respiratory distress syndrome are uncertain.
