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临床试验/NCT04039152
NCT04039152已完成不适用

Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit at a Tertiary Care Hospital: A Prospective Quasi Experimental Clinical Study

Assiut University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2019年1月3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
1,200
试验地点
1
主要终点
28-days mortality in each group

研究概览

简要总结

Antimicrobial resistance is one of the biggest and most urgent threat to global health. Initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance. Implementing these programs in neonatal intensive care units (NICU)is very important and crucial despite of its difficulty, where antibiotics are used extensively. The aim of present study was to assess the clinical impact of implementing antibiotic stewardship program interventions at NICU.

详细描述

Background:

Implementing an antimicrobial stewardship program is one of the main efforts to control antimicrobial resistance. The present study aimed to assess the clinical impact of the antibiotics stewardship program (ASP) in the neonatal intensive care unit (NICU) of Assiut University Children's Hospital.

Methods:

The study was conducted in two phases from January 2019 to June 2020. The pre-ASP phase (603 patients) included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the ASP. The ASP intervention phase (597 patients) included implementation of the ASP, which involved modifying the neonatal sepsis treatment protocol according to the local antibiotic susceptibility patterns and measuring its clinical outcomes.

Results:

研究设计

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

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Received antibiotics for more than 72 hours.

排除标准

  • Hospital stay was less than 72 hours.
  • Did not receive any antibiotics during hospital stay.

结局指标

主要结局

28-days mortality in each group

时间窗: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase

Number of patients who died from neonatal sepsis at the 28th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase

14-days mortality in each group

时间窗: 6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase

Number of patients who died from neonatal sepsis at the 14th day of their hospital stay was compared in the Pre-ASP phase and the ASP intervention phase

次要结局

  • Average Length of hospital stay in each group(6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase)
  • 30-day readmission in each group(6 months in the in the Pre-ASP phase and 6 months in the ASP intervention phase)

研究者

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

Neveen Hassan

Principle investigator

Assiut University

研究点 (1)

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