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临床试验/NCT07109791
NCT07109791尚未招募不适用

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

University of Alberta1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2026年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,500
试验地点
1
主要终点
VAP Incidence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 24 Weeks(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

结局指标

主要结局

VAP Incidence

时间窗: 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

次要结局

  • Other Adverse Outcomes(2025-2028)
  • Prevalence of VAP Among VLBW Infants(2025-2028)
  • VAP Incidence Attributable to AROs(2025-2028)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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National Surveillance and Prevention of Neonatal VAP | 临床试验