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临床试验/NCT02467309
NCT02467309Unknown不适用

Association of Serum 25-hydroxyvitamin D Levels and Outcomes in Children With Bacterial Meningitis

Gang Liu0 个研究点目标入组 50 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
vitamin d level change

研究概览

简要总结

The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.

详细描述

Vitamin D deficiency has been proved in serious diseases patients, including patients in shock, however, few study have been done about association between deficiency of Vitamin D and outcomes of children with bacterial meningitis.

in our study, we will observe incidence of complication and severity of complication between patients who have different Vitamin D status.

研究设计

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

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 °C rectal or 38.0 °C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following:
  • A. turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl)
  • Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis

排除标准

  • Congenital immunodeficiency patients
  • HIV patients
  • Patients with corticosteroid treatment for long time
  • Patients with disorders in adrenal gland and pituitary gland and hypothalamus
  • Patients with tuberculosis

结局指标

主要结局

vitamin d level change

时间窗: change in serum vitamin d level from baseline to 28 days after initial hospitalization

Serum vitamin d level will be detected in the first day of hospitalization and twenty-eighth day of hospitalization, no vitamin d supplementation during this time

次要结局

  • Clinical assessment of disease severity with Glasgow score(28 day)
  • Clinical assessment of disease severity with cerebrospinal fluid examination(28 day)
  • Assessment of complications(28 day)
  • Clinical assessment of disease severity with pediatric critical illness score(28 day)

研究者

发起方
Gang Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gang Liu

director, chief physician, professor

Beijing Children's Hospital

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