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NCT Number: NCT07109791

National Surveillance and Prevention of Neonatal VAP

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.

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Key information

Conditions

Ventilator-Associated Pneumonia (VAP), Neonatal Antibiotic-Resistant Organisms (AROs) Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia (BPD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cross Infection Disease Attributes Female Urogenital Diseases and Pregnancy Complications Health-Care Associated Infection (HAI) Healthcare-Associated Pneumonia Iatrogenic Disease Infant, Newborn, Diseases Infant, Premature, Diseases Infections Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Pregnancy Complications Premature Birth Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 24 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location contact

Alena Tse-Chang, Pediatric Infectious Diseases Physician, MD

CONTACT

[email protected]

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

CONTACT

[email protected]

+1(780) 248-5408

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. VAP Incidence

    Time frame: 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 outcomes

  1. Prevalence of VAP Among VLBW Infants

    Time frame: 2025-2028

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

  2. Other Adverse Outcomes

    Time frame: 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

  3. VAP Incidence Attributable to AROs

    Time frame: 2025-2028

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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor

CONTACT

[email protected]

+1(780) 248-5408

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • McGill University
  • University of British Columbia
  • University of Calgary
  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 7, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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