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Trial record 22 of 579 for:    meningitis

Vitamin d Levels in Children With Bacterial Meningitis

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ClinicalTrials.gov Identifier: NCT02467309
Recruitment Status : Unknown
Verified May 2015 by Gang Liu, Beijing Children's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Gang Liu, Beijing Children's Hospital

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

Condition or disease
Bacterial Meningitis

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Association of Serum 25-hydroxyvitamin D Levels and Outcomes in Children With Bacterial Meningitis
Study Start Date : May 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. vitamin d level change [ Time Frame: 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


Secondary Outcome Measures :
  1. Clinical assessment of disease severity with Glasgow score [ Time Frame: 1 day ]
    Disease severity will be assessed with Glasgow score in the first day of hospitalization

  2. Clinical assessment of disease severity with Glasgow score [ Time Frame: 7 day ]
    Disease severity will be assessed with Glasgow score in the seventh day of hospitalization

  3. Clinical assessment of disease severity with Glasgow score [ Time Frame: 28 day ]
    Disease severity will be assessed with Glasgow score in the twenty-eighth day of hospitalization

  4. Clinical assessment of disease severity with pediatric critical illness score [ Time Frame: 1 day ]
    Disease severity will be assessed with pediatric critical illness score in the first day of hospitalization

  5. Clinical assessment of disease severity with pediatric critical illness score [ Time Frame: 7 day ]
    Disease severity will be assessed with pediatric critical illness score in the seventh day of hospitalization

  6. Clinical assessment of disease severity with pediatric critical illness score [ Time Frame: 28 day ]
    Disease severity will be assessed with pediatric critical illness score in the twenty-eighth day of hospitalization

  7. Clinical assessment of disease severity with cerebrospinal fluid examination [ Time Frame: 1 day ]
    Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid

  8. Clinical assessment of disease severity with cerebrospinal fluid examination [ Time Frame: 7 day ]
    Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid

  9. Clinical assessment of disease severity with cerebrospinal fluid examination [ Time Frame: 28 day ]
    Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid

  10. Assessment of complications [ Time Frame: 1 day ]
    Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.

  11. Assessment of complications [ Time Frame: 7 day ]
    Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.

  12. Assessment of complications [ Time Frame: 28 day ]
    Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who are diagnosed with bacterial meningitis in infectious diseases department of Beijing Children's Hospital
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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Responsible Party: Gang Liu, director, chief physician, professor, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT02467309     History of Changes
Other Study ID Numbers: 20150203
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Meningitis
Meningitis, Bacterial
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Central Nervous System Infections