Evaluating the Impact of Probiotic Supplementation on Mortality in Preterm and Low Birth Weight Neonates in a Tertiary Care Center: A Randomized Controlled Study

Background: Preterm birth (before 37 weeks of gestation) and low birth weight (under 2500 grams) are major contributors to infant mortality worldwide, particularly in developing countries. India alone sees around 12% of births as preterm and 18% as low birth weight, making this a significant public health concern. Aim: To assess the role of probiotics usage on the mortality in preterm and low birth weight neonates in a tertiary care centre- a randomized control study. Methodology: The study involved newborns between 28–36 weeks of gestation or weighing less than 1800 grams, admitted to the NICU at Sharda Hospital and meeting specific inclusion criteria. After obtaining informed consent from parents, data was collected using a structured case form. Participants were randomly assigned to two equal groups (A and B) through a computer-generated block randomization method, with allocation concealed in sealed, numbered envelopes. To ensure objectivity, both the medical team and investigators were blinded to group assignments. The probiotic (Bacillus clausii) and placebo (sterile water) were coded and packed separately, with only the designated nurse aware of which was which. Each baby received 2.5 mL of either the probiotic or placebo orally every 12 hours along with feeds, continued until discharge or death, and paused if feeds were stopped. Results: A total of 112 neonates were enrolled, equally divided into placebo (n=56) and probiotic (n=56). 9 neonates died in placebo group, 1 died in probiotic group and 102 were discharged. Demographics: Gestational age, gender, and birth weight were comparable in both groups. Mortality: Significantly lower in the probiotic group. Conclusion: Based on the findings, the administration of probiotics was associated with reduced mortality rates. Mortality was notably higher in the placebo group compared to the probiotic group