National Surveillance and Prevention of Neonatal VAP

NCT ID: NCT07109791

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-09-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Maximum Eligible Age: 24 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor

Role: CONTACT

joseph.ting@ualberta.ca

+1(780) 248-5408

Christie (Zixuan) Li, Clinical Research Coordinator, BSc, MSc

Role: CONTACT

christie.zx.li@ualberta.ca

Facility Contacts

Joseph Ting, Staff Neonatologist and Associate Professor, MD, MPH

Role: primary

joseph.ting@ualberta.ca

+1(780) 248-5408

Alena Tse-Chang, Pediatric Infectious Diseases Physician, MD

Role: backup

awtse@ualberta.ca

Other Identifiers

202409-197813

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00149177

Identifier Type: -

Identifier Source: org_study_id