Impact of Probiotics Supplementation on Enteral Feed Tolerance in Very Low Birth Weight Neonates: An Open Label Randomised Controlled Trial

Introduction: Probiotics are live microorganisms recognised for their potential health benefits. While the evidence regarding their effectiveness in improving feed tolerance among Very Low Birth Weight (VLBW) newborns remains inconclusive, this study seeks to investigate whether probiotic supplementation can significantly reduce the time it takes for VLBW neonates to achieve full feeding. Aim: To study the impact of probiotics supplementation on enteral feed tolerance in very low birth weight neonates. Materials and Methods: An open-label, randomised-controlled trial was conducted at the Neonatal Intensive Care Unit of a tertiary care center, PGIMS, Rohtak, Haryana. All the study participants were screened and enrolled based on the eligibility criteria from September 2022- January 2024. A total of 100 participants were recruited and divided equally into two groups (n=50 each): the probiotic group and the control group. The probiotic group received 1 gm of multistrain probiotics in breast milk. The control group received breast milk with 1 gm of formula milk powder and no probiotics. Statistical analysis was done using appropriate tests for baseline characteristics, and primary and secondary outcomes, and a p-value <0.05 was considered to be statistically significant. Results: Neonates in the probiotic group achieved full feeds much earlier, averaging 4.22±2.88 days as compared to 9.56±3.56 days in the control group (p-value <0.001). They also had a shorter hospital stay of 17.68±3.48 days versus 29.6±2.59 days. Moreover, the incidence of Necrotising Enterocolitis (NEC) and sepsis was significantly lower in the probiotic group (p-values of 0.05 and 0.04), underscoring the positive health effects of probiotics on neonatal well-being. Conclusion: This study concluded that probiotics should be used in very low birth weight neonates as soon as the feed is started which can reduce the time to attain full feeds, duration of hospital stay, and also preventing from potential complications such as sepsis, necrotising enterocolitis.