About this trial
The goal of this observational study is to improve how hospital-acquired lung infections (called ventilator-associated pneumonia, or VAP) are diagnosed, treated and prevented in very low birth weight (VLBW) infants, babies born very early (preterm) or very small who often require respiratory support in hospital's neonatal intensive care units (NICUs).
The main questions it aims to answer are:
* How often do very-low-birth-weight (VLBW) infants get ventilator-associated pneumonia (VAP) in hospitals across Canada? * How often are these VAP infections caused by germs that are resistant to antimicrobials (also known as antimicrobial-resistant organisms or AROs)? * What types of antimicrobial-resistant germs (AROs) are causing them? * How are these infections being treated with antibiotics, and can we reduce unnecessary antibiotic use? * Which diagnostic definition is the best and most accurate for diagnosing VAP in newborns, based on real patient data and expert agreement? * Can we use this information to create clear, evidence-based guidelines that help hospitals prevent and treat VAP in the same, effective way?
Researchers will compare how different hospitals define, report, and manage VAP to devise a shared, evidence-based approach that will lead to more accurate diagnoses and better treatment and outcomes for neonatal VAP.
Researchers will:
* Use data already collected in hospital records (per existing standard of clinical care). * Analyse how often VAP occurs, how it is diagnosed, and how it is treated * Work with experts and hospitals to develop and implement a standard, evidence-based plan for diagnosing, managing and preventing VAP in newborns
The overarching goal is to create a clear, nationwide approach to ensure hospitals across Canada care for preterm babies in a standardized manner, reduce infection rates, avoid unnecessary antibiotic use, and improve outcomes for these vulnerable infants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All VLBW infants admitted to participating tertiary NICUs in Canada
All neonatal VAP events diagnosed based on the physicians' discretion
Disqualifiers
Infants with major congenital anomalies
Infants with moribund status on admission
Trial population
STUDY POPULATION: The study population will include all VLBW infants admitted to participating tertiary NICUs in Canada from 2025-2028 inclusive, diagnosed with VAP at physicians' discretion during their admission.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
VAP Incidence
The number of VAP events per 1000 ventilator-days, per the three distinct definitions (Years 1-4). Unit of Measure: Number of VAP events
Secondary outcomes
Prevalence of VAP Among VLBW Infants
The proportion of VLBW infants with at least 1 episode of VAP Unit of Measure: Percentage of participants (%)
Other Adverse Outcomes
VAP Recurrence Rate Description: Proportion of participants who experience a recurrence of ventilator-associated pneumonia (VAP) during the study period Unit of Measure: Percentage of participants (%) Mortality Rate Description: Number of participants who die during the study period Unit of Measure: Number of participants Number of Participants Diagnosed with Bronchopulmonary Dysplasia (BPD) Description: Number of participants who develop BPD Unit of Measure: Number of participants Need for Invasive Mechanical Ventilation (IMV) at 36 Weeks Corrected Gestational Age Description: Number of participant
VAP Incidence Attributable to AROs
ARO-related VAP events; and the duration of antimicrobial treatment.
Sponsors and contacts
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University of Alberta
Lead sponsor
University of Calgary
Collaborator
University of British Columbia
Collaborator
University of Toronto
Collaborator
McGill University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: