RESULTS
A total of 150 neonates were randomized to one of the two groups of LISA and InSurE (Fig. 1). Baseline characteristics were comparable in both groups (Table 1). The mean gestational Age was 31.4 weeks (±0.53 SD), whereas the mean birth weight of the population was 1243.94g (± 212.60 SD). All the babies were followed till discharge/death. Table.2 depict Primary and secondary outcomes. We observed statistically insignificant difference in the need for intubation within 72 h of birth between the InSurE and LISA group [Relative Risk(RR) of 1.0, 95% of Confidence Interval(CI) 0.68–1.47).Complications like IVH, hsPDA, Pneumothorax, BPD, LOS, NEC, and ROP were more in the InSurE group, however, the difference was statistically insignificant. There was no difference in requirement of the second dose of surfactant between two groups. Also, difference was statistically insignificant in the duration of need for NIPPV,mechanical ventilation and supplemental oxygen. Adverse events during the procedure such as transient desaturation/bradycardia were more in the InSurE group but the P-value was not significant. Furthermore, insignificant statistical difference was seen in the duration of hospital stay and survival outcome among the two groups.
TABLE -1.Baseline characteristics of study groups