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临床试验/NCT03079245
NCT03079245已完成不适用

Improving Antimicrobial Prescribing Practices in the Neonatal Intensive Care Unit

Columbia University6 个研究点 分布在 1 个国家目标入组 6,184 人开始时间: 2009年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,184
试验地点
6
主要终点
Overall Antimicrobial Use measured as days of therapy per 100 patient-days

研究概览

简要总结

To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall and inappropriate antimicrobial use in the neonatal intensive care unit (NICU), a pre-post study was performed in 4 NICUs.

详细描述

Antimicrobial stewardship can improve the safety and quality of healthcare, reduce antimicrobial resistance, and reduce healthcare costs. However, the optimal strategies for the NICU population are unknown and few studies have evaluated the impact of stewardship in this population. To determine if 3 randomly assigned bundles of stewardship interventions would reduce overall and inappropriate antimicrobial use in the NICU. The investigators hypothesized that the bundle using all three interdisciplinary antimicrobial stewardship strategies (education, computer decision support and prescriber audit and feedback) would more effectively reduce overall and inappropriate antimicrobial use compared to usual care. A pre-post intervention study (one baseline year without interventions - May 1, 2009 - April 30, 2010, followed by two years of interventions - May 1, 2010 - April 30, 2012) was performed in 4 academically affiliated, level III NICUs. The sites were randomly assigned to usual care, one intervention, two interventions, or three interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • infants admitted to study NICUs <7 days of age who remained hospitalized 4 days or more days

排除标准

  • Infants admitted to study NICUs 7 days of age and older who were hospitalized less than 4 days

结局指标

主要结局

Overall Antimicrobial Use measured as days of therapy per 100 patient-days

时间窗: Through study completion for 2 years

The indications for initiation of intravenous antimicrobials were categorized as initiation of empiric therapy (antibiotics started prior to culture results), definitive therapy (culture results available prior to initiation of antibiotics), or prophylaxis (e.g., antibiotics for postoperative prophylaxis).

次要结局

  • Length of therapy per 100 patient-days(Through study completion for 2 years)
  • Inappropriate Antimicrobial Use(Through study completion for 2 years)
  • Number of infants initiated on ineffective empiric therapy(Through study completion for 2 years)
  • Proportion of infants treated for culture negative late onset sepsis(Through study completion for 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa Saiman

Professor of Pediatrics

Columbia University

研究点 (6)

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