Routinary probiotic Lactobacillus rhamnosus GG administration in preterm very-low-birth-weight neonates: A retrospective, 6-year cohort study from two large tertiary NICUs in Italy

Background: Probiotics are important in restoring gut normal microbiota, and/or in preventing its disturbances. Several data from neonatal studies disclose efficacy of certain mixtures of probiotics in preventing NEC, ameliorating feeding tolerance, and preventing gut fungal colonization. Nevertheless, concerns still exist about safety and tolerability of routinary, long-lasting administration of living microorganisms in immature patients. We report a 6-year clinical experience from two large tertiary NICUs in Italy. Design/methods: Retrospective study by review of patient charts on infants with birth weight Standard protocol of administration of Lactobacillus GG in the two NICUs consisted of 3 × 10 9 CFU/day, in a single oral dose, since the 4th day of life, for 3 to 4 week courses. Nutritional policy in the two NICUs relied on administration of fresh, expressed maternal milk, whenever possible, and supplementation of premature formaulae when needed. Data about safety and tolerance to probiotic administration, concomitant sepsis, feeding tolerance, and microbiological clinical and surveillance cultures, were retrieved and analysed. Results: During the study period, 811 VLBW infants (mean birth weight 1056 g [± 88]; mean gestational age 29.5 weeks [± 1.1]) were born at the two facilities and survived till discharge. Complete data were obtained for 743 of them. A total number of 17,108 doses of the probiotic LGG were administered (mean 23.1 per infant). No adverse effects or intolerances putatively attributable to LGG occurred. Over the study period, 5350 clinical and surveillance cultures from 13 different sites or devices were performed (7.2 mean cultures from 6.5 mean different sites per infant). None of these cultures ever grew Lactobacillus GG, or other Lactobacilli; no episode of sepsis was attributable to LGG. Full enteral feeding was achieved at 19.2 mean days-of-life [± 8]; 73% of the infants were fed exclusive or partial maternal milk. 14 cases of NEC occurred (1.9%), among them 5 (0.7%) were > stage 2b. Conclusions: Routinary use of probiotic Lactobacillus GG in two large Italian NICUs over a 6-year period was safe and well tolerated. No isolation of Lactobacillus GG from clinical and surveillance cultures occurred. No clinical episode of sepsis attributable to Lactobacillus GG was recorded.