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.

Pediatrics
|November 20, 2013
PubMed

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.
Abstract

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