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Benefits of Bifidobacterium breve M-16V Supplementation in Preterm Neonates - A Retrospective Cohort Study
Sanjay K Patole1,2, Shripada C Rao3,2, Anthony D Keil4
1Department of Neonatal Paediatrics, King Edward Memorial Hospital for Women, Perth, Australia.
Insights
Routine probiotic supplementation with Bifidobacterium breve M-16V significantly reduced necrotising enterocolitis (NEC) in preterm neonates <34 weeks. Further research is needed for extremely preterm infants <28 weeks.
Area of Science:
- Neonatal medicine
- Gastroenterology
- Microbiome research
Background:
- Systematic reviews indicate probiotics lower necrotising enterocolitis (NEC) risk in preterm infants.
- Necrotising enterocolitis (NEC) is a serious condition affecting premature newborns.
Purpose of the Study:
- To evaluate the impact of routine probiotic supplementation (RPS) on NEC incidence in preterm neonates.
- To assess the effect of RPS on NEC and all-cause mortality.
Main Methods:
- A comparative study analyzed NEC and mortality rates over 24 months before and after RPS with Bifidobacterium breve M-16V.
- The study included neonates born before 34 weeks gestation.
- Multivariate logistic regression adjusted for confounding factors.
Main Results:
- RPS significantly reduced NEC (≥ Stage II) from 3% to 1% (aOR=0.43) and combined NEC or mortality from 9% to 5% (aOR=0.53) in neonates <34 weeks.
- No significant reduction in all-cause mortality alone was observed (7% vs. 4%, aOR=0.58).
- Benefits were not statistically significant in the subgroup of neonates <28 weeks, though trends suggested improvement. No cases of probiotic-associated sepsis were reported.
Conclusions:
- Routine probiotic supplementation with Bifidobacterium breve M-16V is effective in reducing NEC and combined NEC or mortality in preterm neonates <34 weeks.
- Larger studies are necessary to confirm the benefits of RPS in extremely preterm infants (<28 weeks).
- Bifidobacterium breve M-16V supplementation is safe, with no reported cases of sepsis.
Background:
Systematic reviews of randomised controlled trials report that probiotics reduce the risk of necrotising enterocolitis (NEC) in preterm neonates.
Aim:
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.
Conclusion:
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.
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