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临床试验/NCT02763709
NCT02763709Unknown不适用

Evaluation of Pediatric Critical Illness Neuropathy/Myopathy in Pediatric Intensive Care Unit

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
97
试验地点
1
主要终点
Incidence of Pediatric critical illness polyneuropathy/myopathy

研究概览

简要总结

Intensive Care Unit Acquired Weakness(ICUAW) encompasses a spectrum of disorders characterized by generalized weakness developing after the onset of critical illness. Pediatric data on the incidence of ICUAW is restricted to isolated case reports and case series of no more than five children. Critical illness polyneuropathy is characterized by reduction in compound motor action potential or sensory nerve action potential or both with preserved conduction velocity on electrophysiological studies. These findings can occur very early prior to the onset of clinical features. Given the dearth of data in children on the subject, this study has been planned to evaluate the incidence of critical illness associated polyneuropathy /myopathy in severely sick children admitted.

详细描述

Materials and Methods

Study Setting: Pediatric Intensive Care Unit, Advanced Pediatric Centre, Postgraduate Institute of Medical Educational Research

Study Period: Jan 2016 to Dec 2016

Study design: Prospective Cohort Study

Study Population: Children of 2 years to 12 years of age

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
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children admitted in Pediatric Intensive Care Unit for more than 24 hours
  • Pediatric Risk of Mortality (PRISM) score III > 20

排除标准

  • Previous (Eg: Diabetes Mellitus, Systemic Lupus Erythematosus, Dermatomyositis, Spinal Muscular Atrophy) or current neuromuscular disorder (e.g Guillian Barre Syndrome, snake bite, myositis)
  • Use of drugs causing neuromuscular blockade
  • Bilateral Lower limb disorders precluding Nerve Conduction Study or ElectroMyoGraphy (Gross edema, fractures, amputation, plaster casts, open wounds, infections)
  • Children with abnormal electrophysiological studies at baseline examination will be excluded

结局指标

主要结局

Incidence of Pediatric critical illness polyneuropathy/myopathy

时间窗: 1 month

次要结局

未报告次要终点

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ananthanarayanan

Senior resident

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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