Surfactant Administration in Preterm babies (28-36 weeks) with Respiratory Distress Syndrome: LISA vs InSurE, an Open-Label Randomized Controlled Trial

ABSTRACT INtubation- SURfactant-Extubation (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 favourable effects of LISA can’t be extrapolated from developed to developing countries. Aim of Study is to compare the effectiveness of InSurE and LISA. Objectives: Primary outcome was to find need of intubation and mechanical ventilation within 72 hrs of birth. Neonates were followed until discharge/death for adverse events and complications. Material: & Methods : Open-label 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. Results: : Total of 150 neonates were analysed (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]. 12% (n=9, LISA group) & 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 & mortality. Conclusion: : : 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. Keywords- Intubation, Mechanical Ventilation, NIPPV.