Prophylactic probiotics to prevent death and nosocomial infection in preterm infants

Abstract

Background and objective: It has been suggested that probiotics may decrease infant mortality and nosocomial infections because of their ability to suppress colonization and translocation of bacterial pathogens in the gastrointestinal tract. We designed a large double-blinded placebo-controlled trial using Lactobacillus reuteri to test this hypothesis in preterm infants.

Methods: Eligible infants were randomly assigned during the first 48 hours of life to either daily probiotic administration or placebo. Infants in the intervention group were administered enterally 5 drops of a probiotic preparation containing 10(8) colony-forming units of L reuteri DSM 17938 until death or discharge from the NICU.

Results: A total of 750 infants ≤ 2000 g were enrolled. The frequency of the primary outcome, death, or nosocomial infection, was similar in the probiotic and placebo groups (relative risk 0.87; 95% confidence interval: 0.63-1.19; P = .376). There was a trend toward a lower rate of nosocomial pneumonia in the probiotic group (2.4% vs 5.0%; P = .06) and a nonsignificant 40% decrease in necrotizing enterocolitis (2.4% vs 4.0%; P = .23). Episodes of feeding intolerance and duration of hospitalization were lower in infants ≤ 1500 g (9.6% vs 16.8% [P = .04]; 32.5 days vs 37 days [P = .03]).

Conclusions: Although L reuteri did not appear to decrease the rate of the composite outcome, the trends suggest a protective role consistent with what has been observed in the literature. Feeding intolerance and duration of hospitalization were decreased in premature infants ≤ 1500 g.

Trial registration: ClinicalTrials.gov NCT00727363.