National Surveillance and Prevention of Neonatal VAP

NCT07109791 | Recruiting

• 2 other identifiers: Pro00149177202409-197813
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Preterm; Neonate; Neonatal intensive care unit (NICU); Ventilator-Associated Pneumonia (VAP); Healthcare-associated infections (HAI); Invasive mechanical ventilation (IMV); Bronchopulmonary dysplasia (BPD); Antibiotic-resistant organisms (AROs); Antimicrobial stewardship; Implementation science; Quality improvement (QI); Infection surveillance

Outcome Measures

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

  2025-2028

Secondary Outcomes (3)

• Prevalence of VAP Among VLBW Infants

  2025-2028

• Other Adverse Outcomes

  2025-2028

• VAP Incidence Attributable to AROs

  2025-2028

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 24 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator
• University of British Columbia: collaborator
• University of Toronto: collaborator
• McGill University: collaborator

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 41526087 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Bronchopulmonary Dysplasia; Cross Infection; Premature Birth

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor

CONTACT

+1(780) 248-5408; joseph.ting@ualberta.ca

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

CONTACT

christie.zx.li@ualberta.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 7, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)