Effectiveness of Prebiotics and Probiotics with Breast Milk Vs Breast Milk Alone in Prevention of Sepsis in Neonates - A Randomised Controlled Trial

Abstract

Introduction: Neonatal sepsis is not an uncommon phenomenon in neonates, and it has been noted that India has high incidence of neonatal sepsis with high case fatality rates as well. Therefore, it is thus of utmost importance to discover ways and preventive measures to prevent sepsis in these neonates. A combination of breast milk with prebiotics plus probiotic agents seems to be promising modality in preventing neonatal sepsis according to few scientific publications.

Objective: This study was undertaken to evaluate the effectiveness of the prebiotics and probiotics with breast milk versus breast milk alone in prevention of sepsis in neonates.

Method: This prospective, randomized control trial was conducted in NICU of tertiary care hospital in Maharashtra, India from 1st November 2019 to 31st October 2021.

Results:  A total of 280 neonates were enrolled in study. 140 neonates who received prebiotic and probiotics with breast milk were categorized in group A, while 140 neonates who received only breast milk were categorized in group B. Majority of the enrolled neonates were male, term, AGA neonates in both the groups. Of the 140 neonates in group A, 136 neonates had no sepsis (97.14%), while in group B 76 neonates (54.28%) had no sepsis. In group A, 2 neonates had probable sepsis while 2 neonates had proven sepsis. In group B, 15 neonates had probable sepsis while 49 neonates had proven sepsis. This difference in between study groups was noted to be statistically significant (p<0.05 by chi-square test).

Conclusion: Administration of prebiotics and probiotics with breast milk was found to be significantly effective in preventing sepsis in neonates, in comparison to breast milk alone. However more research in this field will help in validating our study findings.