title: Necrotising enterocolitis and mortality in preterm infants after introduction of probiotics: a quasi-experimental study.
abstract: Evidence on the clinical effectiveness of probiotics in the prevention of necrotising enterocolitis (NEC) in preterm infants is conflicting and cohort studies lacked adjustment for time trend and feeding type. This study investigated the association between the introduction of routine probiotics (Lactobacillus acidophilus and Bifidobacterium bifidum; Infloran(®)) on the primary outcome 'NEC or death'. Preterm infants (gestational age <32 weeks or birth weight <1500 gram) admitted before (Jan 2008-Sep 2012; n = 1288) and after (Oct 2012-Dec 2014; n = 673) introduction of probiotics were compared. Interrupted time series logistic regression models were adjusted for confounders, effect modification by feeding type, seasonality and underlying temporal trends. Unadjusted and adjusted analyses showed no difference in 'NEC or death' between the two periods. The overall incidence of NEC declined from 7.8% to 5.1% (OR 0.63, 95% CI 0.42-0.93, p = 0.02), which was not statistically significant in the adjusted models. Introduction of probiotics was associated with a reduced adjusted odds for 'NEC or sepsis or death' in exclusively breastmilk-fed infants (OR 0.43, 95% CI 0.21-0.93, p = 0.03) only. We conclude that introduction of probiotics was not associated with a reduction in 'NEC or death' and that type of feeding seems to modify the effects of probiotics.
authors.affiliation: Erasmus MC, Department of Paediatrics, division of Neonatology, Rotterdam, 3000 CB, The Netherlands.
authors.forename: Noor
authors.initials: N
authors.lastname: Samuels
authors.affiliation: Erasmus MC, Department of Paediatrics, division of Neonatology, Rotterdam, 3000 CB, The Netherlands.
authors.forename: Rob
authors.initials: R
authors.lastname: van de Graaf
authors.affiliation: Erasmus MC, Department of Paediatrics, division of Neonatology, Rotterdam, 3000 CB, The Netherlands.
authors.forename: Jasper V
authors.initials: JV
authors.lastname: Been
authors.affiliation: Erasmus MC, Department of Paediatrics, division of Neonatology, Rotterdam, 3000 CB, The Netherlands.
authors.forename: Rogier C J
authors.initials: RC
authors.lastname: de Jonge
authors.affiliation: Erasmus MC, Department of Hospital Pharmacy, Rotterdam, 3000 CB, The Netherlands.
authors.forename: Lidwien M
authors.initials: LM
authors.lastname: Hanff
authors.affiliation: Erasmus MC l, Department of Paediatric Surgery, Rotterdam, 3000 CB, The Netherlands.
authors.forename: René M H
authors.initials: RM
authors.lastname: Wijnen
authors.affiliation: Erasmus MC, Department of Paediatrics, division of Neonatology, Rotterdam, 3000 CB, The Netherlands.
authors.forename: René F
authors.initials: RF
authors.lastname: Kornelisse
authors.affiliation: Erasmus MC, Department of Paediatrics, division of Neonatology, Rotterdam, 3000 CB, The Netherlands.
authors.forename: Irwin K M
authors.initials: IK
authors.lastname: Reiss
authors.affiliation: Erasmus MC, Department of Paediatrics, division of Neonatology, Rotterdam, 3000 CB, The Netherlands.
authors.forename: Marijn J
authors.initials: MJ
authors.lastname: Vermeulen
mesh_terms: D000069985:Bifidobacterium bifidum; D020345:Enterocolitis, Necrotizing / Q000401:mortality / Q000628:therapy; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007779:Lactobacillus acidophilus; D008297:Male; D019936:Probiotics / Q000008:administration & dosage*