Using Antibiotics Wisely - An Antimicrobial Stewardship Program

Study Overview
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Brief Summary
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There are significant variations in antimicrobial consumption across Canadian Neonatal Intensive Care Units (NICUs). Inappropriate and overuse of antibiotics can result in antimicrobial resistance and adverse outcomes among vulnerable neonatal populations. There are limited data on broad-spectrum antimicrobial use, multi-drug resistant organisms (MDRO) prevalence, and effective NICU-specific antimicrobial stewardship strategies. The aim of this study is to develop and implement NICU-specific antimicrobial stewardship strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of MDROs.

Detailed Description
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Purpose: The investigators aim to develop and implement NICU-specific Antimicrobial Stewardship Program (ASP) strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of multi-drug resistant organisms (MDRO) in Canada. Hypothesis: The investigators expect to find: Significant national variation in broad-spectrum antimicrobial use, which will not be correlated with rates of sepsis. High antimicrobial consumption rates may be associated with limited existing ASP resources and increased neonatal morbidity related to inflammatory cascades. Significant national variation in the prevalence of MDROs across NICUs. Differences in empirical antimicrobial regimens may be associated with MDRO prevalence, and the variation in antimicrobial use may explain some variation in neonatal morbidity. Study Population and Sample Size: The study population will include very-low-birth-weight (VLBW) infants (i.e., the group of infants neonates with the highest risk of infections within NICUs) admitted to participating tertiary NICUs in Canada.

Official Title
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Using Antibiotics Wisely - Development of National Neonatal Intensive Care Unit-specific ASP

Conditions
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Multi-Drug Resistant Organisms, Late-Onset Sepsis, Neonatal, Antimicrobial Resistance

Intervention / Treatment
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* Other: Exposure of interest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Very-low-birth-weight infants admitted to participating tertiary NICUs in Canada. Exclusion Criteria: infants with major congenital anomalies

Ages Eligible for Study
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Minimum Age: 22 Weeks
Maximum Age: 44 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Exposure of interest|Very Low Birth Weight infants admitted to tertiary NICUs in Canada.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of therapy/1000 patient-day of each category of antimicrobial consumption |  | 2020-2025 | 
| Prevalence of multi-drug resistant organisms in infections among very-low-birth-weight neonates during their NICU stay |  | 2020-2025 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between multi-drug resistant organisms, broad-spectrum antimicrobial use, neonatal outcomes and existing Antimicrobial Stewardship Programs & screening policies. |  | 2020-2025 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antimicrobial Stewardship, Prematurity, Neonate