1. Probiotic supplementation in very preterm infants reduced the incidence of necrotizing enterocolitis (NEC), Bell Stage 2 and greater, but not late-onset sepsis or all-cause mortality. Number needed to treat was 43 infants to prevent 1 NEC episode.
2. No adverse effects were reported with probiotic supplementation.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Late-onset sepsis complicates approximately 15% of preterm births, and is associated with a 15% mortality rate. Preterm infants’ gastrointestinal (GI) systems are colonized by nosocomial and potentially pathologic bacteria that put them at higher risk for sepsis and necrotizing enterocolitis (NEC) than full-term infants colonized with maternal flora. Previous studies have suggested that probiotic supplementation reduces the incidence of NEC and all-cause mortality, but its effects on late-onset sepsis are not well-defined. This randomized controlled trial examined probiotic usage in very preterm infants < 32 weeks gestational age and < 1500 g birth weight, but did not have sufficient power to evaluate differential benefits by stratifying patients into subgroups by age or weight. Researchers confirmed reduction of definite NEC with probiotic supplementation, but found no effect on late-onset sepsis or all-cause mortality when compared to controls. No adverse effects of probiotic supplementation were noted. Given the benefits noted in this large trial, this study supports the usage of probiotic supplementation in very preterm infants to reduce the incidence of NEC. Further studies are recommended to reevaluate conflicting evidence on all-cause mortality, and potential effects of probiotic supplementation on specific groups of preterm neonates.
Study Author, Dr. Suzanne M. Garland, MD, talks to 2 Minute Medicine: Director of Microbiological Research and Head of Clinical Microbiology and Infectious Diseases: Royal Women’s Hospital, Senior Consultant Microbiology: Royal Children’s Hospital, Honorary Research Fellow, Murdoch Childrens Research Institute,
“In the world’s largest series to date in a randomised controlled trial of 1100 babies of 10 centres, 8 from Australia, 2 from New Zealand, necrotising enterocolitis in infants less than 1500 g and less than 32 weeks gestation, given the probiotics combination of Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis, halved the rate of necrotising enterocolitis. Probiotics are a cheap, safe and easy intervention and I would envisage be adopted globally in NICU for these vulnerable infants.”
In-Depth [randomized controlled trial]: This double-blind, placebo-controlled trial enrolled 1099 very preterm neonates across a total of 10 centers in Australia and New Zealand. Very preterm infants were defined as < 32 weeks gestational age and weighing < 1500 g at birth. Infants were enrolled within 72 hours of birth and then randomized to receive either probiotic (Bifidobacterium infantis, Streptococcus thermophilus, Bifidobacterium lactis) supplementation or placebo powder mixed in breast-milk or formula. Infants continued to receive intervention or placebo until discharge or term-corrected age. Risk of NEC was defined by Bell staging ranging from Stage I (suspected NEC) to III (advanced NEC). A decrease in NEC, Bell Stage II (definite NEC) or greater, was noted in the trial arm when compared to controls (relative risk = 0.46, 95% CI 0.23-0.93, P = 0.03). No significant differences in late-onset sepsis or all-cause mortality were identified between the groups. The number of infants needed to undergo supplementation in order to eliminate 1 NEC occurrence was 43. A subset of infants born at 28-32 weeks gestation and weighing greater than 1000 g at birth showed a potential decrease in late-onset sepsis with probiotic supplementation; however, lack of sufficient statistical power did not allow for adequate validation of this finding. No adverse effects, including sepsis secondary to probiotic organisms, were reported.
By Neha Joshi and Leah H. Carr
Reviewed by William V. Raszka, MD
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