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临床试验/NCT04967066
NCT04967066已完成不适用

Serum Levels of Adipocytokines in Children With Febrile Seizures: A Cross-Sectional Study at Sohag University Hospital

Sohag University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年8月23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
90
试验地点
1
主要终点
Serum leptin

研究概览

简要总结

Febrile seizure (FS) is a common neurological condition in children, affecting 2 - 14% of children. FS is defined as seizures occurring in a child aged from six months to five years that is accompanied by a fever (≥38°C) without central nervous system infection. FS is classified into simple febrile seizure (SFS) and complex febrile seizure (CFS). SFS accounts for 70-75% of FS cases and is characterized by being generalized, duration of less than 15 minutes, occurs once in 24 hours, and no previous neurologic problems. We aim to investigate serum levels of adipocytokines, specifically leptin, adiponectin, and IL-6, in children with FS.

详细描述

The study will include three groups of children (100 for each): children with febrile seizures (group 1), febrile children without seizures (group 2), and healthy control children (group 3). Children included in this study will undergo:

  • Thorough medical history taking: including age, gender, and seizure details for children with febrile seizures (e.g., type, duration, recurrence).

  • Physical examination: including vital signs (particularly temperature) and comprehensive neurological examination).

  • Laboratory investigations:

  • Routine investigations: complete blood count, C-reactive protein, blood glucose, serum electrolytes (sodium, potassium, calcium, and magnesium), liver and kidney function tests.

  • Serum leptin and adiponectin: venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin and adiponectin will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
6 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age from 6 months to 6 years.
  • Seizures.
  • Fever (≥38°C) due to acute infection.
  • Presented for routine check-up.

排除标准

  • Central nervous system infection.
  • Epilepsy.
  • Previous neurological abnormalities.
  • Inborn errors of metabolism.
  • Immunological diseases.
  • Endocrinal diseases (e.g., diabetes mellitus).
  • Eating disorders.
  • Gastrointestinal disorders (e.g., diarrhea).
  • Seizures.
  • Previous neurological abnormalities
  • Any illness in the last month

结局指标

主要结局

Serum leptin

时间窗: within 3 hours of seizures

venous blood samples (3 ml) will be obtained from children with FS as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

Serum adiponectin

时间窗: within 3 hours of seizures

venous blood samples (3 ml) will be obtained from children with FS as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum adiponectin will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.

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

Hagar Abdelhamid Mohamed

Resident of Pediatrics, Sohag University Hospital

Sohag University

研究点 (1)

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