National Surveillance and Prevention of Neonatal VAP

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 24
SponsorUniversity of Alberta

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants
are grouped into 1 trial group
Group A: VLBW infants with VAP Diagnosis

Trial outcomes

Primary outcomes

1

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

Time frame
2025-2028

Secondary outcomes

1

Prevalence of VAP Among VLBW Infants

The proportion of VLBW infants with at least 1 episode of VAP Unit of Measure: Percentage of participants (%)

Time frame
2025-2028
2

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

Time frame
2025-2028
3

VAP Incidence Attributable to AROs

ARO-related VAP events; and the duration of antimicrobial treatment.

Time frame
2025-2028

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: