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临床试验/NCT01443611
NCT01443611已完成不适用

The Relevance of Performing Lumbar Puncture in Infants Aged 3 to 12 Months With First Episode of Febrile Convulsion

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
1
主要终点
Number of patients with abnormal lumbar puncture

研究概览

简要总结

The actual recommendations for infants aged 3 to 12 months presented with first episode of Febrile Convulsions highly recommend performing lumbar puncture in order to rule out Bacterial Meningitis. On the other hand, recent studies in the era of anti Pneumococcal vaccination arise the question if in the presence of a normal physical examination those recommendations are still relevant. The purpose of this study is to summarized retrospectively the clinical records of all the infants admitted to the pediatric wards in the ten years period since 2000 to 2010 in order to record the incidence of Bacterial Meningitis among infants admitted with the First episode of Febrile Convulsions.

详细描述

Demographic data, including ethnic origin, age an gender will be recorded. The type of Convulsions (Simple or Complex), duration, and time since the fever was noticed will be also recorded. Another data that will be summarized included: previous antibiotic treatment, physical examination with special emphasis on neurological examination and meningeal signs, routine laboratory analysis including blood count and cerebrospinal fluid (CSF) results and the final diagnosis including the cause of fever.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
3 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants aged 3 to 12 months who presents with First Episode of Febrile Convulsions during the period 1/1/2000 until 31/12/2010

排除标准

  • infants with previous neurological diseases, or
  • recent neurological disease that are not included in the characteristics of Febrile Convulsion

结局指标

主要结局

Number of patients with abnormal lumbar puncture

时间窗: One year

The number of patients aged six months to one year that underwent lumbar puncture when they were admitted with simple febrile convulsions

次要结局

未报告次要终点

研究者

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

Dr Koren Ariel

Head of Pediatric Dpt B and Pediatric Hematology Unit

HaEmek Medical Center, Israel

研究点 (1)

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