Banked Human Milk and Quantitative Risk Assessment of Bacillus cereus Infection in Premature Infants: A Simulation Study

Background. Banked human milk (BHM) offers potential health benefits to premature babies. BHM is pasteurized to mitigate infectious risks, but pasteurization is ineffective against sporulating bacteria such as Bacillus cereus. Sepsis related to Bacillus cereus in premature infants is severe and can...

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Main Authors: Antoine Lewin, Gilles Delage, France Bernier, Marc Germain
Format: Article
Language:English
Published: Wiley 2019-01-01
Series:Canadian Journal of Infectious Diseases and Medical Microbiology
Online Access:http://dx.doi.org/10.1155/2019/6348281
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author Antoine Lewin
Gilles Delage
France Bernier
Marc Germain
author_facet Antoine Lewin
Gilles Delage
France Bernier
Marc Germain
author_sort Antoine Lewin
collection DOAJ
description Background. Banked human milk (BHM) offers potential health benefits to premature babies. BHM is pasteurized to mitigate infectious risks, but pasteurization is ineffective against sporulating bacteria such as Bacillus cereus. Sepsis related to Bacillus cereus in premature infants is severe and can often be fatal. Even if a causal link has never been established, BHM has been suggested as a potential source of infection in premature infants. Objective. Our aim was to estimate the potential risk of Bacillus cereus infection in preterm infants caused by the ingestion of contaminated pasteurized BHM using different post-pasteurization release criteria (i.e., 9 sampling of 100 microliters versus the HMBANA guideline of 1 sampling of 100 microliters per pool). Methods. In the absence of scientific evidence regarding the risk of Bacillus cereus infection by the ingestion of BHM in premature infants, risk assessment using Monte Carlo simulation with the exponential dose-response model was performed. Three scenarios of infectious risk (annual incidence rate of 0.01%, 0.13%, and 0.2%) with 18 variations of the B. cereus virulent dose (from 0.5 CFU/ml to 200 CFU/ml) were simulated. Results. The mean risk differential between the two methods of post-pasteurization bacteriological control for realistic infectious doses of 30 to 200 CFU/ml ranges from 0.036 to 0.0054, 0.47 to 0.070, and 0.72 to 0.11 per million servings, for each of the three scenarios. Conclusion. Simulation highlights the very small risk of Bacillus cereus infection following the ingestion of pasteurized BHM, even in the worst case scenarios, and suggests that a 100-microliter sample for post-pasteurization culture is sufficient.
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spelling doaj-art-ac6279f0302a4eaba2fc7b2e1b40b1e52025-08-20T03:39:14ZengWileyCanadian Journal of Infectious Diseases and Medical Microbiology1712-95321918-14932019-01-01201910.1155/2019/63482816348281Banked Human Milk and Quantitative Risk Assessment of Bacillus cereus Infection in Premature Infants: A Simulation StudyAntoine Lewin0Gilles Delage1France Bernier2Marc Germain3Medical Affairs and Innovation, Héma-Québec, Montreal, QC, CanadaMedical Affairs and Innovation, Héma-Québec, Montreal, QC, CanadaQuality and Regulatory Affairs, Héma-Québec, Montreal, QC, CanadaMedical Affairs and Innovation, Héma-Québec, Québec, QC, CanadaBackground. Banked human milk (BHM) offers potential health benefits to premature babies. BHM is pasteurized to mitigate infectious risks, but pasteurization is ineffective against sporulating bacteria such as Bacillus cereus. Sepsis related to Bacillus cereus in premature infants is severe and can often be fatal. Even if a causal link has never been established, BHM has been suggested as a potential source of infection in premature infants. Objective. Our aim was to estimate the potential risk of Bacillus cereus infection in preterm infants caused by the ingestion of contaminated pasteurized BHM using different post-pasteurization release criteria (i.e., 9 sampling of 100 microliters versus the HMBANA guideline of 1 sampling of 100 microliters per pool). Methods. In the absence of scientific evidence regarding the risk of Bacillus cereus infection by the ingestion of BHM in premature infants, risk assessment using Monte Carlo simulation with the exponential dose-response model was performed. Three scenarios of infectious risk (annual incidence rate of 0.01%, 0.13%, and 0.2%) with 18 variations of the B. cereus virulent dose (from 0.5 CFU/ml to 200 CFU/ml) were simulated. Results. The mean risk differential between the two methods of post-pasteurization bacteriological control for realistic infectious doses of 30 to 200 CFU/ml ranges from 0.036 to 0.0054, 0.47 to 0.070, and 0.72 to 0.11 per million servings, for each of the three scenarios. Conclusion. Simulation highlights the very small risk of Bacillus cereus infection following the ingestion of pasteurized BHM, even in the worst case scenarios, and suggests that a 100-microliter sample for post-pasteurization culture is sufficient.http://dx.doi.org/10.1155/2019/6348281
spellingShingle Antoine Lewin
Gilles Delage
France Bernier
Marc Germain
Banked Human Milk and Quantitative Risk Assessment of Bacillus cereus Infection in Premature Infants: A Simulation Study
Canadian Journal of Infectious Diseases and Medical Microbiology
title Banked Human Milk and Quantitative Risk Assessment of Bacillus cereus Infection in Premature Infants: A Simulation Study
title_full Banked Human Milk and Quantitative Risk Assessment of Bacillus cereus Infection in Premature Infants: A Simulation Study
title_fullStr Banked Human Milk and Quantitative Risk Assessment of Bacillus cereus Infection in Premature Infants: A Simulation Study
title_full_unstemmed Banked Human Milk and Quantitative Risk Assessment of Bacillus cereus Infection in Premature Infants: A Simulation Study
title_short Banked Human Milk and Quantitative Risk Assessment of Bacillus cereus Infection in Premature Infants: A Simulation Study
title_sort banked human milk and quantitative risk assessment of bacillus cereus infection in premature infants a simulation study
url http://dx.doi.org/10.1155/2019/6348281
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