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临床试验/NCT02167802
NCT02167802已完成不适用

Construction and Validation of a Tool for Automatic Identification of Care Pathways At Risk of Sub-optimality in the Management of Severe Infections in Children (DIABACT IV)

Nantes University Hospital12 个研究点 分布在 1 个国家目标入组 524 人开始时间: 2015年3月20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
524
试验地点
12
主要终点
the optimality of care questionnaire

研究概览

简要总结

Community bacterial infection remains to this day a common cause of morbidity and mortality in children, which preventability is a challenge for clinicians. In a previous work, the investigators found that 76% supported children admitted to the ICU for severe bacterial infection were appraised as suboptimal and significantly associated with an increased risk of death. In this context, the investigators seek to identify indicators of extractable data PMSI and SNIIR -AM associated with a higher risk of suboptimal early taking care of children with severe bacterial infection in order to combine them and use them as a score or decision tree that the investigators will validate data from a national prospective multicenter study including 512 children admitted to the ICU for severe infection. The investigators then propose a score associated with a risk of suboptimality care to evaluate the performance of the healthcare system .

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 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Nosocomial Infections as defined by the Ministry of Health in its January 2007 issue on nosocomial infections namely: Nosocomial infections are infections acquired in a healthcare facility. Infection is considered nosocomial if it was absent at the time of admission of the patient in the health facility. When the infectious status of the patient at admission is unknown, the infection is generally considered nosocomial if it occurs after a period of at least 48 hours of hospitalization or a period longer than the incubation period of the infection. In case of surgical site infection, the period commonly allowed is 30 days, or if it has been set in place a prosthesis or implant, a year after the intervention.
  • Children with whooping cough, bronchiolitis or viral infections

结局指标

主要结局

the optimality of care questionnaire

时间窗: 1 month

optimality of care will be assessed by 2 independent experts, blinded to outcome and final diagnosis. Medical charts will be summarized and given to experts without outcome or diagnosis. They would be asked to evaluate optimality of care as follow: optimal, certainly sub-optimal, possibly suboptimal and not evaluable

次要结局

  • outcome at the hospital discharge defined as death, survival without sequelae and survival with sequelae(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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