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comparisional analysis of two drugs used for complex neurological condition (ADEM) in childre

Phase 3
Completed
Conditions
Health Condition 1: G040- Acute disseminated encephalitis and encephalomyelitis (ADEM)Health Condition 2: G040- Acute disseminated encephalitis and encephalomyelitis (ADEM)Health Condition 3: null- children with acute disseminated encephalomyelitis
Registration Number
CTRI/2017/11/010618
Lead Sponsor
Banaras Hindu University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
33
Inclusion Criteria

All children admitted in emergency pediatric ward with â??

Clinical feature â??

1.unilateral or bilateral pyramidal sign, 2.Acute hemiplegia,

3.ataxia,

4. cranial Nerve Palsy,

5.seizure,

6.vision loss due to optic neuritis, impairment of speech (slow, slurred or aphasia) 7.hemiparesis,

8.change in mental status (ranging from lethergy to coma) with

9.normal cerebrospinal fluid studies and 10.suggestive MR imaging i.e. increased signal intensity on T2 weighted image & fluid attenuated inversion recovery sequence (FLAIR) as large, globular, multiple and asymmetric lesion.

Exclusion Criteria

1.Children with acute bacterial and tubercular meningitis

2.intracranial space occupying lesion,

3.underlying known autoimmune and connective tissue disorder will be excluded from the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
neurological recoveryTimepoint: 7 days, 1 month, 3 months
Secondary Outcome Measures
NameTimeMethod
adverse reaction of intravenous immunoglobulin treatmentTimepoint: three months;duration of stay in hospitalTimepoint: nil;residual neurological deficitTimepoint: three months
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