National Surveillance and Prevention of Neonatal VAP

Recruiting

• Conditions: Ventilator-Associated Pneumonia (VAP), Neonatal; Bronchopulmonary Dysplasia (BPD); Antibiotic-Resistant Organisms (AROs); Health-Care Associated Infection (HAI)

• Registration Number: NCT07109791
• Lead Sponsor: University of Alberta

Brief Summary

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.

Detailed Description

PURPOSE: The purpose of this study is to develop neonatal-specific diagnostic criteria and management guidelines for VAP in VLBW infants in Canadian NICUs, and to improve clinical outcomes through better surveillance, diagnosis, management and antimicrobial stewardship.

HYPOTHESIS:

* We expect substantial variability in VAP incidence across the participating NICUs.

* We expect notable differences in the proportion of VAP events attributable to AROs and in the duration of antimicrobial treatment administered.

AIMS/OBJECTIVES:

1. Aim 1: To characterise neonatal VAP incidence by collecting data on infants diagnosed with VAP using three commonly applied definitions, while also identifying AROs, and evaluating patterns of antimicrobial use for VAP treatment across tertiary NICUs.

2. Aim 2: To identify the most appropriate, neonatal-specific VAP diagnostic definition by integrating systematically collected clinical data, statistical analyses, and expert consensus through Delphi methodology.

3. Aim 3: To translate these findings into practice by developing evidence-based clinical guidelines and tailored implementation strategies for VAP prevention and management.

STUDY POPULATION AND SAMPLE SIZE: The study population will include all VLBW infants (i.e., the group of infants neonates with the highest risk of infections within NICUs) admitted to participating tertiary NICUs in Canada with diagnoses of VAP at physicians' discretion.

RESEARCH METHODS: This project is a multi-centre prospective cohort study, conducted in collaboration with a network of tertiary NICUs in Canada.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Study Start: 2025-09-01
• Primary Completion: 2029-06
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAP Incidence	2025-2028	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 Outcome Measures

Name	Time	Method
Other Adverse Outcomes	2025-2028	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
Prevalence of VAP Among VLBW Infants	2025-2028	The proportion of VLBW infants with at least 1 episode of VAP Unit of Measure: Percentage of participants (%)
VAP Incidence Attributable to AROs	2025-2028	ARO-related VAP events; and the duration of antimicrobial treatment.

Trial Locations

Locations (1)

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada