Surfactant administration in preterm babies (28-36 weeks) with respiratory distress syndrome: LISA versus InSurE, an open-label randomized controlled trial.

Abstract

INtubate-SURfactant-Extubate (InSurE) approach is traditional method of surfactant delivery in preterm neonates with respiratory distress syndrome (RDS).Newer, less invasive surfactant administration (LISA) techniques lessen the need for mechanical ventilation and its adverse consequences. Evidence on the favorable effects of LISA can't be extrapolated from developed to developing countries. Aim of study is to compare the effectiveness of InSurE and LISA. Primary outcome was to find need of intubation and mechanical ventilation within 72 h of birth. Neonates were followed until discharge/death for adverse events and complications. MATERIALS ANDMETHODS: Open-label randomized controlled trial(RCT) was conducted at tertiary neonatal intensive care unit. Preterm neonates with diagnosis of RDS were randomized in two groups (InSurE or LISA) to receive surfactant soon after birth. Nasal intermittent positive pressure ventilation (NIPPV) was used as primary mode of respiratory support. A total of 150 neonates were analyzed (75 in each group). Insignificant statistical difference was seen in the need for intubation and mechanical ventilation within 72 h of birth between the two groups (InSurE, 30 [40%] and LISA, 30 [40%], relative risk 1.0, 95% confidence interval 0.68-1.48). Twelve percent (n = 9, LISA group) and 14.6% (n = 11 InSurE group) had adverse events during the procedure. Also, we observed insignificant statistical difference in the rates of major complications or duration of respiratory support, hospital stay, and mortality. LISA and InSurE are equally effective for surfactant administration in the treatment of RDS, when NIPPV is the primary mode of respiratory support. More RCTs are required to compare the efficacy & long-term outcomes of LISA with InSurE.