title: Double-blind, randomised clinical assay to evaluate the efficacy of probiotics in preterm newborns weighing less than 1500 g in the prevention of necrotising enterocolitis.
abstract: BACKGROUND
  A randomised, double-blind clinical trial was undertaken in order to assess the effectiveness of probiotics in the prevention of necrotising enterocolitis (NEC) in newborns weighing <1500 g.
  
  
  METHODS
  We studied a group of 150 patients who were randomised in two groups after parental consent was obtained, to receive either a daily feeding supplementation with a multispecies probiotic (Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Bifidobacteruim infantis, Streptococcus thermophillus) 1 g per day plus their regular feedings or to receive their regular feedings with nothing added (control group), over the period of January 2007 through June 2010. Clinicians in care of the infants were blinded to the group assignment.
  
  
  RESULTS
  The primary outcome was the development of NEC. Both groups were comparable, with no differences during hospitalisation, including the type of nutrition received. Blood cultures obtained from cases that developed sepsis did not reveal lactobacillus or Bifidobacteria growth. No differences were detected in terms of NEC risk reduction (RR: 0.54, 95% CI 0.21 to 1.39) although we did observe a clear trend in the reduction of NEC frequency in the studied cases: 6 (8%) versus 12 (16%) in the control group. When the combined risk of NEC or death was calculated as a post hoc analysis, we found a significantly lower risk (RR: 0.39, 95% CI 0.17 to 0.87) for the study group.
  
  
  CONCLUSIONS
  Probiotics may offer potential benefits for premature infants and are a promising strategy in the reduction of the risk of NEC in preterm newborns.
authors.affiliation: Neonatology Department, Instituto Nacional de Perinatología, Montes Urales 800 CP 11000, México.
authors.forename: Luis Alberto
authors.initials: LA
authors.lastname: Fernández-Carrocera
authors.forename: Aide
authors.initials: A
authors.lastname: Solis-Herrera
authors.forename: Marisol
authors.initials: M
authors.lastname: Cabanillas-Ayón
authors.forename: Rocío Beatriz
authors.initials: RB
authors.lastname: Gallardo-Sarmiento
authors.forename: Carmina Sarisol
authors.initials: CS
authors.lastname: García-Pérez
authors.forename: Rosalba
authors.initials: R
authors.lastname: Montaño-Rodríguez
authors.forename: Maria Olga Leticia
authors.initials: MO
authors.lastname: Echániz-Aviles
mesh_terms: D004311:Double-Blind Method; D020345:Enterocolitis, Necrotizing / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D008297:Male; D019936:Probiotics / Q000627:therapeutic use*; D016896:Treatment Outcome