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.
Highlights
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
The study population consisted of two groups, defined by the moment of introduction of probiotics; one group represented those born before introduction of probiotics (Group 1; January 1, 2008 until October 1, 2012); the other those born after introduction of probiotics (Group 2; October 1, 2012 until January 1, 2015)
The unadjusted analysis suggested an association between introduction of probiotics and reduction of Necrotising enterocolitis (NEC) incidence, but this was not statistically significant in the models adjusted for feeding type and underlying time trend
Summary
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. The recent large RCT on Bifidobacterium (B.) breve illustrated that probably not every probiotic strain has an effect[13] Another issue is that probiotics are not licenced as drugs in most countries[14]. Evaluation of clinical use of L. acidophilus and B. bifidum has been communicated at scientific meetings only[16,17,18] These studies concerned small populations and used analyses without adjustment for relevant confounders such as type of feeding and underlying time trend. We designed a large observational study www.nature.com/scientificreports/
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