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临床试验/CTRI/2018/10/016130
CTRI/2018/10/016130尚未招募不适用

Implementation and Assessment of Ventilator Associated Pneumonia bundle strategy to prevent ventilator associated pneumonia in Neonatal Intensive Care Unit

Not applicable1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2018年2月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
450
试验地点
1
主要终点
To evaluate the incidence of VAP pre and post implementation of VAPB

研究概览

简要总结

To reduce the incidence of VAP and reduce the associated morbidity and mortality.

Aim of the study is to Implement and Assess ventilator associated pneumonia in Neonatal intensive care unit. The study will be conducted between october 2018- March 2019.

All neonates admitted to NICU during study period and utilized mechanical ventilation for ≥ 48 hours.

It is a time dependent study with three phases, Phase 1, Phase 2 and Phase 3 wherein Phase 1  will assessed to check the incidence rate of VAP in mechanically ventilated newborns, to check the adherence of VAP bundle and debriefing if any errors in practice, The observations will be documented by the primary investigator.

In phase 2,  â€œVAP prevention bundle will be tailored according to common errors found out in Phase I and include common evidence-based practices recommended by previous studies and agencies. We will be performing education session to discuss evidences about the pathogenesis, risk factors, danger of VAP and its sequel and the need for VAP bundle. Training and re-training campaigns will be performed for each VAP bundle’s item.

Phase 3 is a post VAP bundle implementation phase, re-evaluation of VAP rate to assess the efficacy of the infection control bundle.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
1.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • All neonates admitted to NICU during study period and utilized mechanical ventilation for ≥ 48 hours.

排除标准

  • Neonates who will be empirically started on antibiotics before mechanical ventilation -Out-hospital intubations.

结局指标

主要结局

To evaluate the incidence of VAP pre and post implementation of VAPB

时间窗: Before and after implementation of VAP Bundle

次要结局

  • To assess the effect of each bundle component on the VAP incidence(The correlation between full adherence to the VAPB and VAP incidence)

研究者

申办方类型
Other [Not applicable]

研究点 (1)

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