National Surveillance and Prevention of Neonatal VAP

University of Alberta

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07109791

202409-197813 (Other Grant/Funding Number)

Pro00149177

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: Under 24 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

VLBW infants with VAP Diagnosis

Description:

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.