The study was supported by the Women's and Infant's Research Foundation of Western Australia. Professor Hart is Medical Director of Fertility Specialists of Western Australia (FSWA) and a shareholder Western IVF. He has received educational sponsorship from MSD, Merck-Serono and Ferring Pharmaceuticals. T.H. is a consultant with FSWA and a shareholder in Western IVF. She has received educational sponsorship from MSD, Merck-Serono and Ferring Pharmaceuticals. The other authors have no competing interests.
BackgroundProbiotic supplementation significantly reduces the risk of necrotising enterocolitis (NEC) and all cause mortality in preterm neonates. Independent quality assessment is important before introducing routine probiotic supplementation in this cohort.AimTo assess product quality, and confirm that Bifidobacterium breve (B. breve) M-16V supplementation will increase fecal B. breve counts without adverse effects.Methods and ParticipantsStrain identity (16S rRNA gene sequencing), viability over 2 year shelf-life were confirmed, and microbial contamination of the product was ruled out. In a controlled trial preterm neonates (Gestation <33 weeks) ready to commence or on feeds for <12 hours were randomly allocated to either B. breve M-16V (3×109 cfu/day) or placebo (dextrin) supplementation until the corrected age 37 weeks. Stool samples were collected before (S1) and after 3 weeks of supplementation (S2) for studying fecal B. breve levels using quantitative PCR (Primary outcome). Secondary outcomes included total fecal bifidobacteria and NEC≥Stage II. Categorical and continuous outcomes were analysed using Chi-square and Mann-Whitney tests, and McNemar and Wilcoxon signed-rank tests for paired comparisons.ResultsA total of 159 neonates (Probiotic: 79, Placebo: 80) were enrolled. Maternal and neonatal demographic characteristics were comparable between the groups. The proportion of neonates with detectable B. breve increased significantly post intervention: Placebo: [S1:2/66 (3%), S2: 25/66 (38%), p<0.001] Probiotic: [S1: 29/74 (40%), S2: 67/74 (91%), p<0.001].Median S1 B. breve counts in both groups were below detection (<4.7 log cells.g−1), increasing significantly in S2 for the probiotic group (log 8.6) while remaining <4.7 log in the control group (p<0.001). There were no adverse effects including probiotic sepsis and no deaths. NEC≥Stage II occurred in only 1 neonate (placebo group).Conclusion B. breve M-16V is a suitable probiotic strain for routine use in preterm neonates.Trial RegistrationAustralia New Zealand Clinical Trial Registry ACTRN 12609000374268
Background: Early-onset sepsis (EOS) is a potentially fatal condition that affects about 0.3–0.8/1,000 infants born at ≥35 weeks’ gestation in developed countries. Current EOS management algorithms result in 8–15% of infants receiving antibiotics for suspected sepsis. The Neonatal Sepsis Calculator provides evidence-based estimates of individual sepsis risk, but data on its clinical application is limited. Objectives: To evaluate the feasibility, safety, and effect on the newborn infants that were investigated and that received antibiotic treatment for suspected EOS following the introduction of the Neonatal Sepsis Calculator. Methods: This was a prospective, observational, single-centre cohort study comparing the rates of newborn infants born at ≥35 weeks’ gestation requiring evaluation and/or treatment for suspected EOS in a large tertiary perinatal centre before versus after the prospective introduction of the Neonatal Sepsis Calculator (Epoch 1: October 2014 to January 2015 vs. Epoch 2: July to December 2016). Results: There were 1,732 and 2,502 eligible infants born during Epochs 1 and 2, respectively. Of these, 425 (24.2%) and 530 (21.2%), respectively, were admitted to the neonatal unit. The proportion of infants investigated for sepsis decreased from 15.2 to 11.1%, and that of infants treated with antibiotics from 12.0 to 7.6%. One case of EOS occurred during each Epoch. Conclusions: The implementation of the Neonatal Sepsis Calculator was feasible and safe in our unit. Application of this clinical decision support tool may reduce the number of infants undergoing investigations and empirical treatment for suspected EOS.
BackgroundSystematic reviews of randomised controlled trials report that probiotics reduce the risk of necrotising enterocolitis (NEC) in preterm neonates.AimTo determine whether routine probiotic supplementation (RPS) to preterm neonates would reduce the incidence of NEC.MethodsThe 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.ResultsA 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.ConclusionRPS 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.
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