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Published on: January 27, 2019
Probiotic Supplementation and Late-Onset Sepsis in Preterm Infants: A Meta-analysis
Shripada C Rao1, Gayatri K Athalye-Jape2, Girish C Deshpande3
1Neonatal ICU, King Edward Memorial Hospital for Women, Perth, Western Australia; Neonatal ICU, Princess Margaret Hospital for Children, Perth, Western Australia; Centre for Neonatal Research and Education, School of Pediatrics and Child Health, University of Western Australia, Perth, Western Australia; shripada.rao@health.wa.gov.au.
Insights
Probiotic supplementation significantly reduces the risk of late-onset sepsis (LOS) in preterm infants. This meta-analysis of 37 trials confirms probiotics as a beneficial approach for neonatal care.
Area of Science:
- Neonatal Medicine
- Microbiome Research
- Clinical Trials
Background:
- Late-onset sepsis (LOS) is a critical concern for preterm infants, contributing to mortality and morbidity.
- Existing preventive measures are insufficient, necessitating novel strategies like probiotic supplementation.
- Previous reviews (e.g., Cochrane 2014) showed no clear benefit, but more recent trials exist.
Purpose of the Study:
- To systematically review all relevant randomized controlled trials (RCTs) on probiotic use in preterm infants.
- To assess the efficacy of probiotics in reducing the incidence of LOS.
- To provide an updated meta-analysis incorporating recent research.
Main Methods:
- Comprehensive literature search across multiple databases (PubMed, Embase, Cochrane, CINAHL) and conference proceedings.
- Inclusion of RCTs comparing probiotics with placebo or no probiotic intervention.
- Independent data extraction by three reviewers and meta-analysis using a fixed effects model.
Main Results:
- Pooled analysis of 37 RCTs (N=9416) demonstrated a significant reduction in LOS risk with probiotics (13.9% vs 16.3%).
- The relative risk for LOS was 0.86 (95% CI, 0.78-0.94; P=.0007), with a number needed to treat of 44.
- Statistical significance was maintained even when excluding studies with a high risk of bias.
Conclusions:
- Probiotic supplementation is an effective strategy for reducing the risk of late-onset sepsis in preterm infants.
- The findings support the integration of probiotics into neonatal care protocols for high-risk infants.
- Further research may explore optimal probiotic strains and dosages.
Context:
Late-onset sepsis (LOS) is a major cause of mortality and morbidity in preterm infants. Despite various preventive measures, its incidence continues to remain high, hence the urgent need for additional approaches. One such potential strategy is supplementation with probiotics. The updated Cochrane Review (2014) did not find benefits of probiotics in reducing the risk of LOS in preterm infants (19 studies, N = 5338). Currently there are >30 randomized controlled trials (RCTs) of probiotics in preterm infants that have reported on LOS.
Objectives:
To conduct a systematic review including all relevant RCTs.
Data Sources:
PubMed, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature, and E-abstracts from the Pediatric Academic Society meetings and other pediatric and neonatal conference proceedings were searched in June and August 2015.
Study Selection:
RCTs comparing probiotics versus placebo/no probiotic were included.
Data Extraction:
Relevant data were extracted independently by 3 reviewers.
Results:
Pooled results from 37 RCTs (N = 9416) using fixed effects model meta analysis showed that probiotics significantly decreased the risk of LOS (675/4852 [13.9%] vs 744/4564 [16.3%]; relative risk, 0.86; 95% confidence interval, 0.78-0.94; P = .0007; I(2) = 35%; number needed to treat, 44). The results were significant even after excluding studies with high risk of bias.
Conclusions:
Probiotic supplementation reduces the risk of LOS in preterm infants.

