title: Benefits of Bifidobacterium breve M-16V Supplementation in Preterm Neonates - A Retrospective Cohort Study.
abstract: BACKGROUND
  Systematic reviews of randomised controlled trials report that probiotics reduce the risk of necrotising enterocolitis (NEC) in preterm neonates.
  
  
  OBJECTIVE
  To determine whether routine probiotic supplementation (RPS) to preterm neonates would reduce the incidence of NEC.
  
  
  METHODS
  The incidence of NEC ≥ Stage II and all-cause mortality was compared for an equal period of 24 months 'before' (Epoch 1) and 'after' (Epoch 2) RPS with Bifidobacterium breve M-16V in neonates <34 weeks. Multivariate logistic regression analysis was conducted to adjust for relevant confounders.
  
  
  RESULTS
  A total of 1755 neonates (Epoch I vs. II: 835 vs. 920) with comparable gestation and birth weights were admitted. There was a significant reduction in NEC ≥ Stage II: 3% vs. 1%, adjusted odds ratio (aOR) = 0.43 (95%CI: 0.21-0.87); 'NEC ≥ Stage II or all-cause mortality': 9% vs. 5%, aOR = 0.53 (95%CI: 0.32-0.88); but not all-cause mortality alone: 7% vs. 4%, aOR = 0.58 (95% CI: 0.31-1.06) in Epoch II. The benefits in neonates <28 weeks did not reach statistical significance: NEC ≥ Stage II: 6% vs. 3%, aOR 0.51 (95%CI: 0.20-1.27), 'NEC ≥ Stage II or all-cause mortality', 21% vs. 14%, aOR = 0.59 (95%CI: 0.29-1.18); all-cause mortality: 17% vs. 11%, aOR = 0.63 (95%CI: 0.28-1.41). There was no probiotic sepsis.
  
  
  CONCLUSIONS
  RPS with Bifidobacterium breve M-16V was associated with decreased NEC≥ Stage II and 'NEC≥ Stage II or all-cause mortality' in neonates <34 weeks. Large sample size is required to assess the potential benefits of RPS in neonates <28 weeks.
authors.affiliation: Department of Neonatal Paediatrics, King Edward Memorial Hospital for Women, Perth, Australia.|Centre for Neonatal Research and Education, University of Western Australia, Perth, Australia.
authors.forename: Sanjay K
authors.initials: SK
authors.lastname: Patole
authors.affiliation: Department of Neonatal Paediatrics, Princess Margaret Hospital for Children, Perth, Australia.|Centre for Neonatal Research and Education, University of Western Australia, Perth, Australia.
authors.forename: Shripada C
authors.initials: SC
authors.lastname: Rao
authors.affiliation: PathWest Laboratory Medicine Western Australia, Perth, Australia.
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Keil
authors.affiliation: Women and Infants Research Foundation, King Edward Memorial Hospital for Women, Perth, Australia.|School of Women's and Infants' Health, University of Western Australia, Perth, Australia.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Nathan
authors.affiliation: Women and Infants Research Foundation, King Edward Memorial Hospital for Women, Perth, Australia.|School of Women's and Infants' Health, University of Western Australia, Perth, Australia.
authors.forename: Dorota A
authors.initials: DA
authors.lastname: Doherty
authors.affiliation: Department of Neonatal Paediatrics, King Edward Memorial Hospital for Women, Perth, Australia.|Centre for Neonatal Research and Education, University of Western Australia, Perth, Australia.
authors.forename: Karen N
authors.initials: KN
authors.lastname: Simmer
mesh_terms: D001644:Bifidobacterium; D015331:Cohort Studies; D019587:Dietary Supplements / Q000009:adverse effects; D020345:Enterocolitis, Necrotizing / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D005865:Gestational Age; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D017063:Outcome Assessment, Health Care; D019936:Probiotics / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies