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Published on: January 27, 2019
Probiotic effects on late-onset sepsis in very preterm infants: a randomized controlled trial
Susan E Jacobs1, Jacinta M Tobin, Gillian F Opie
1Women's Centre for Infectious Diseases, Bio 21 Institute, 30 Flemington Rd, Parkville 3052, Victoria, Australia. suzanne.garland@thewomens.org.au.
Insights
This study found that a specific probiotic combination did not reduce late-onset sepsis or mortality in very preterm infants. However, it did significantly decrease the incidence of necrotizing enterocolitis (NEC).
Area of Science:
- Neonatal Medicine
- Microbiome Research
- Clinical Trials
Background:
- Late-onset sepsis is a significant cause of morbidity and mortality in premature infants.
- Probiotics show potential in reducing necrotizing enterocolitis (NEC) and mortality in preterm infants, but their effect on late-onset sepsis is unclear.
Purpose of the Study:
- To investigate the impact of a specific probiotic combination on culture-proven late-onset sepsis in very preterm infants.
- To assess the safety and efficacy of probiotics in preventing sepsis and NEC.
Main Methods:
- A prospective, multicenter, double-blinded, placebo-controlled, randomized trial was conducted.
- Very preterm infants (born before 32 weeks gestation, weighing <1500 g) received daily probiotics (Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis) or placebo.
- The primary outcome measured was the occurrence of definite late-onset sepsis.
Main Results:
- The study included 1099 very preterm infants. Rates of sepsis, NEC, and mortality were low in the control group.
- No significant difference was observed in definite late-onset sepsis or all-cause mortality between the probiotic and placebo groups.
- The probiotic combination significantly reduced NEC of Bell stage 2 or more (2.0% vs. 4.4%, P = .03).
Conclusions:
- The specific probiotic combination effectively reduced NEC in very preterm infants.
- This probiotic regimen did not significantly impact late-onset sepsis or mortality rates.
- The administration of this probiotic combination was found to be safe for very preterm infants.
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 probiotic combination (Bifidobacterium infantis, Streptococcus thermophilus, and Bifidobacterium lactis, containing 1 × 10(9) 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.
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