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A Controlled Mouse Model for Neonatal Polymicrobial Sepsis
Published on: January 27, 2019
Incidence of probiotic sepsis and morbidity risk in premature infants: a meta-analysis
Keith Feldman1,2, Janelle R Noel-MacDonnell1,2, Lucy B Pappas3
1Division of Health Services and Outcomes Research, Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO, USA.
Insights
Probiotic sepsis is very rare in preterm infants. The benefits of probiotics in preventing necrotizing enterocolitis (NEC) and other morbidities outweigh the minimal risks of sepsis.
Area of Science:
- Neonatal Medicine
- Microbiology
- Clinical Research
Background:
- Probiotics are used to reduce necrotizing enterocolitis (NEC) and other morbidities in preterm infants.
- Concerns exist regarding probiotic sepsis, with limited incidence data hindering risk-benefit analysis.
- This study quantifies probiotic sepsis risk versus NEC, mortality, and clinical sepsis outcomes.
Purpose of the Study:
- To evaluate the risk-benefit tradeoff of probiotic use in preterm infants.
- To quantify the incidence of probiotic sepsis in this vulnerable population.
- To compare probiotic sepsis risk against NEC, mortality, and clinical sepsis rates.
Main Methods:
- A meta-analysis and review of 160 articles, with 77 selected for analysis.
- Pooled incidence estimates calculated using random-effect models.
- Case reports analyzed for infant demographics, hospital course, and outcomes.
Main Results:
- 8 cases of probiotic sepsis identified among 20,323 exposed preterm infants (<0.04%).
- Risk-benefit analysis: 62 NEC cases, 42 deaths, and 92 clinical sepsis events avoided per probiotic sepsis case.
- Probiotic sepsis primarily occurred in extremely-low-birthweight infants at risk for bacterial translocation.
Conclusions:
- Probiotic sepsis is extremely rare in preterm infants, with identifiable high-risk subpopulations.
- The incidence of probiotic sepsis is low compared to the morbidities it helps prevent.
- A favorable benefit/risk ratio supports probiotic use in preterm infants, warranting careful consideration.
Background:
For preterm infants, supplementation with probiotics improves rates of necrotizing enterocolitis (NEC) and other morbidities. Case reports of probiotic sepsis have prompted warnings from the American Academy of Pediatrics and the Federal Drug Administration. However, incidence rates of probiotic sepsis are lacking, making it challenging to evaluate risk-benefit tradeoffs. We performed a meta-analysis and review of probiotic sepsis events in preterm infants to evaluate tradeoffs against NEC, mortality, and clinical sepsis outcomes.
Methods:
Dual-reviewers screened 160 articles, selecting 77 for review. Pooled estimates of incidence were computed using random-effect models. Case reports captured infant demographics, hospital course, and outcome.
Results:
For 20,323 exposed infants across 63 studies, 8 probiotic sepsis cases were identified [estimate: 0% (95% CI: 0-10%)]. Risk-benefit calculations note an additional 62 cases of NEC, 42 deaths, and 92 clinical sepsis events in the unexposed cohort per case of probiotic sepsis. Case reports identified 27 probiotic sepsis events, mostly in extremely-low-birthweight infants (median GA/BW: 28 weeks, 970.0 g) and those at risk for bacterial translocation.
Conclusion:
Probiotic sepsis is extremely rare in preterm infants, with the greatest risk in an identifiable sub-population. Estimates highlighted increased morbidities in unexposed cohorts compared to probiotic sepsis incidence, suggesting consideration of risk-benefit may be warranted.
Impact:
This study quantifies the risk of probiotic sepsis in preterm infants utilizing a meta-analysis. In over 20,000 exposed infants across 40 randomized trials and 23 observational studies, 8 cases of probiotic sepsis were identified (<0.04%). Assessing this risk against improvements in morbidities with probiotic use, we can expect 62 more cases of NEC, 42 more deaths, and 92 more cases of clinical sepsis per case of probiotic sepsis (1:2500) avoided in the unexposed group. While the use of probiotics carries risk, rates for probiotic sepsis presented by this analysis highlight a favorable benefit/risk ratio in preterm infants.
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