Effects of Probiotics on Late Onset Neonatal Sepsis in Preterm Infants: A Randomized Controlled Trial
Keywords:
Probiotics, Late Onset, Neonatal Sepsis, Preterm InfantsAbstract
Background And Objective: Late-onset neonatal sepsis frequently complicates prematurity, contributing to morbidity and mortality. Probiotics may reduce necrotizing enterocolitis (NEC) in preterm infants, with unclear effect on late-onset sepsis. This study aimed to determine the effect of administering a specific combination of probiotics in reducing the incidence of late onset neonatal sepsis in preterm infants. Methods: This is a prospective single center, double-blinded, placebo controlled, randomized trial compared daily administration of a probiotic with a placebo. Each probiotic capsule contains (500 mg blend)- Lactobacillus acidophilus- 2 billion cfu, Lactobacillus bulgaricus- 1 billion cfu, Bifidobacterium bifidum-1 billion cfu, Fructo-Oligosaccharide- 100 mg and each placebo capsule contains (500 mg blend) Pregelatinised Starch (Starch-1500). Infants born <35 completed weeks, weighing <2000 g admitted in NICU are included in this study. The primary outcome was at least 1 episode of late-onset sepsis. Secondary outcomes include: feeding intolerance, mortality, time to establish full enteral feeds, days required to physiological weight gain, patent ductus arteriosus, intraventricular hemorrhage, retinopathy of prematurity, bronchopulmonary dysplasia, duration of hospital stay. Results: Between 2019 and 2021, 119 preterm infants from NICU, BSMMU were randomized. Rates of definite late-onset sepsis (35.6 %), rates of LONS (definite and clinical) (44.1 %), mortality (13.6 %), feeding intolerance (11.9 %) were statistically significant low in probiotics group than the placebo group. There is more hospital stay, more days to reach full enteral feeds and less weight gain in placebo group and it is statistically significant. Conclusions: This randomized, double blinded, placebo controlled trial has power to demonstrate clinically significant effects of the chosen probiotic mixture on the rate of late-onset sepsis in LBW infants. A large clinical trial is required to address outstanding issues regarding safety and efficacy in this vulnerable population.
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