1. Probiotic Effects on Late-onset Sepsis in Very Preterm Infants: A Randomized Controlled Trial.
- Author
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Jacobs, Susan E., Tobin, Jacinta M., Opie, Gillian F., Donath, Susan, Tabrizi, Sepehr N., Pirotta, Marie, Morley, Colin J., and Garland, Suzanne M.
- Subjects
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NEONATAL diseases , *SEPSIS , *CHI-squared test , *CONFIDENCE intervals , *NEONATAL necrotizing enterocolitis , *PREMATURE infants , *RESEARCH funding , *STATISTICAL sampling , *RANDOMIZED controlled trials , *PROBIOTICS , *RELATIVE medical risk , *BLIND experiment , *DATA analysis software , *CHILDREN , *DISEASE risk factors - Abstract
BACKGROUND AND OBJECTIVE: Late-onset sepsis frequently complicates prematurity, contributing to morbidity and mortality. Probiotics may reduce mortality and 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 to very preterm infants on culture-proven late-onset sepsis. METHODS: A prospective multicenter, double-blinded, placebo- controlled, randomized trial compared daily administration of a pro- biotic combination {Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis, containing 1 x 109 total organisms) with placebo (maltodextrin) in infants born before 32 completed weeks' gestation weighing <1500 g. The primary outcome was at least 1 episode of definite late-onset sepsis. RESULTS: Between October 2007 and November 2011,1099 very preterm infants from Australia and New Zealand were randomized. Rates of definite late-onset sepsis (16.2%), NEC of Bell stage 2 or more (4.4%), and mortality (5.1%) were low in controls, with high breast milk feeding rates (96.9%). No significant difference in definite late-onset sepsis or all-cause mortality was found, but this probiotic combination reduced NEC of Bell stage 2 or more (2.0% versus 4.4%; relative risk 0.46, 95% confidence interval 0.23 to 0.93, P= .03; number needed to treat 43, 95% confidence interval 23 to 333). CONCLUSIONS: The probiotics B infantis, S thermophilus, and B lactis significantly reduced NEC of Bell stage 2 or more in very preterm infants, but not definite late-onset sepsis or mortality. Treatment with this combination of probiotics appears to be safe. [ABSTRACT FROM AUTHOR]
- Published
- 2013
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