National Surveillance and Prevention of Neonatal VAP

Developing a National Approach to Surveillance and Prevention for Neonatal Ventilator-Associated Pneumonia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchopulmonary Dysplasia (BPD); Ventilator-Associated Pneumonia (VAP), Neonatal; Antibiotic-Resistant Organisms (AROs); Health-Care Associated Infection (HAI)

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor; Phone Number: +1(780) 248-5408; Email: joseph.ting@ualberta.ca
• Study Contact Backup: Name: Christie (Zixuan) Li, Clinical Research Coordinator, BSc, MSc; Email: christie.zx.li@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital
      • Contact: Joseph Ting, Staff Neonatologist and Associate Professor, MD, MPH; Phone Number: +1(780) 248-5408; Email: joseph.ting@ualberta.ca
      • Contact: Alena Tse-Chang, Pediatric Infectious Diseases Physician, MD; Email: awtse@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

INCLUSION CRITERIA:

• All VLBW infants admitted to participating tertiary NICUs in Canada
• All neonatal VAP events diagnosed based on the physicians' discretion

EXCLUSION CRITERIA:

• Infants with major congenital anomalies
• Infants with moribund status on admission

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
VLBW infants with VAP Diagnosis; The study population will include all VLBW infants (birth weight <1500g) admitted to participating tertiary NICUs in Canada with diagnoses of VAP at physicians' discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2025-2028

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: University of British Columbia; McGill University; University of Toronto; University of Calgary
• Investigators: Principal Investigator: Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor, University of Alberta

Publications and helpful links

General Publications

• Li CZ, Tse-Chang A, Yoon EW, Paquette V, Roberts A, Afifi J, Yang CL, Khurshid F, Augustine S, Choudhury J, Elsharkawy A, Hamilton C, Hicks M, Joynt C, Wang D, Lee KS, Louis D, Robinson JL, Mohamed A, Mitra S, Shah VS, Srigley JA, Stavel M, Sherlock R, Wong J, Kuan MT, Madise-Wobo AD, Lemyre B, Joly C, Kharrat A, Gupta-Bhatnagar S, Zarembo M, Bacchini F, Beltempo M, Shah PS, Ting JY. Protocol for developing a national approach to surveillance and prevention for neonatal ventilator-associated pneumonia. BMJ Paediatr Open. 2026 Jan 12;10(1):e004234. doi: 10.1136/bmjpo-2025-004234.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: July 21, 2025
• First Submitted That Met QC Criteria: July 30, 2025
• First Posted (Actual): August 7, 2025

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Neonate; Antimicrobial stewardship; Preterm; Implementation science; Bronchopulmonary dysplasia (BPD); Neonatal intensive care unit (NICU); Ventilator-Associated Pneumonia (VAP); Healthcare-associated infections (HAI); Invasive mechanical ventilation (IMV); Antibiotic-resistant organisms (AROs); Quality improvement (QI); Infection surveillance
• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Pneumonia; Iatrogenic Disease; Lung Injury; Ventilator-Induced Lung Injury; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Premature Birth; Pneumonia, Ventilator-Associated; Cross Infection; Bronchopulmonary Dysplasia
• Other Study ID Numbers: Pro00149177; 202409-197813 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: due to data privacy and regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No