Role of Lactobacillus Rhamnosus GG in Prevention of Necrotizing Entrocolitis and Late Onset Sepsis in Preterm Neonates < 35 Weeks: A Randomized Controlled Trial

Background: There is a paucity of RCTs that have systemically evaluated the effects of L.GG on the prevention of NEC and LOS in preterm neonates. To study different incidence rates of NEC and LOS. Secondary outcomes were the incidence of hyperbillirubinaemia, mortality, side effects and weight gain.Methods: This is an open labeled RCT. Preterm infants with a gestational age of < 35 weeks were assigned to three groups: A(L.GG sachet 6 billion organism), B(L.GG drops 2 billion organisms), C (no probiotic) using fixed block randomization. Probiotic was administered till the neonate reached the corrected gestational age of 36 weeks or a maximum of 4 weeks.Results: Of 123 neonates, NEC developed in 2(4.88%) in group A versus 1(2.38%) in group B and 0 (0%) in group C (p value-0.37). LOS also developed in 5(12.2%) in group A versus 3(7.14%) in group B and 3(7.5%) in group C (p -value 0.7). Moreover, 92.68% of subjects were successfully discharged in group A, 95.24% in group B and 90% in group C ( p-value 0.55). A significant difference was found between the incidence of hyperbilirubinemia (21.95% in group A versus 47.5% in group C (p-value 0.02) and 28.92% in Group A+B versus 47.5% in group C (p-value 0.04). There was a significant difference in weight gain at 1 month of age; 9.65 +/- 3.72 grams/kg/day in group A versus 6.58 +/- 3.86 grams/kg/day in group C (p-value 0.002) and 8.98 +/- 4.49 grams/kg/day in group B versus 6.58 +/- 3.86 grams/kg/day in group C (p-value 0.03).Conclusion: L.GG alone as a single strain administered in both high and low dosages has no significant effect on reducing the incidence of NEC, LOS and yielding immediate outcomes. A larger sample size and a blinded study are required to draw more accurate conclusions.