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

intravenous immunoglobulin versus methylprednisolone in children with acute disseminated encephalomyelitis: a randomized control trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/11/010618
Enrollment
52
Registered
2017-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Intervention1: intravenous imunoglobulin(IVIG): intravenous immunoglobulin G (IVIG) at a dosage of 2 g/kg divided over 2 to 5 days Control Intervention1: methylprednisolone: intravenous methylpredniso

Sponsors

Banaras Hindu University
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
neurological recoveryTimepoint: 7 days, 1 month, 3 months

Secondary

MeasureTime frame
adverse reaction of intravenous immunoglobulin treatmentTimepoint: three months;duration of stay in hospitalTimepoint: nil;residual neurological deficitTimepoint: three months

Countries

India

Contacts

Public ContactRajniti Prasad

Banaras Hindu University

goutam.goswami90@gmail.com08601601490

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026