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Using Antibiotics Wisely - An Antimicrobial Stewardship Program

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04388293
Enrollment
2000
Registered
2020-05-14
Start date
2020-01-01
Completion date
2025-09-30
Last updated
2021-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Antimicrobial Stewardship, Prematurity, Neonate

Brief summary

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

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.

Interventions

Very Low Birth Weight infants admitted to tertiary NICUs in Canada.

Sponsors

University of Calgary
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
Memorial University of Newfoundland
CollaboratorOTHER
Children's Hospital of Eastern Ontario
CollaboratorOTHER
Université de Montréal
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
22 Weeks to 44 Weeks
Healthy volunteers
No

Inclusion criteria

* Very-low-birth-weight infants admitted to participating tertiary NICUs in Canada.

Exclusion criteria

* infants with major congenital anomalies

Design outcomes

Primary

MeasureTime frame
Days of therapy/1000 patient-day of each category of antimicrobial consumption2020-2025
Prevalence of multi-drug resistant organisms in infections among very-low-birth-weight neonates during their NICU stay2020-2025

Secondary

MeasureTime frame
Association between multi-drug resistant organisms, broad-spectrum antimicrobial use, neonatal outcomes and existing Antimicrobial Stewardship Programs & screening policies.2020-2025

Countries

Canada

Contacts

Primary ContactJoseph Ting, Associate Prof
joseph.ting@ualberta.ca+1(780)248-5408

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026