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Study of low dose steroids continued after standard treatment on outcome of children with West syndrome

Effect of prolonged low dose oral steroid after standard protocol on electro-clinical and neuro-developmental outcome in children with West Syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017067
Enrollment
20
Registered
2019-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: G408- Other epilepsy and recurrent seizures

Interventions

Intervention1: Low dose Prednisolone: After receiving the standard protocol ( Inj. ACTH for 12 weeks with oral Vigabatrin), Children in intervention arm will receive low dose steroids for 6 months. Co

Sponsors

Bharati Vidyapeeth University Medical College Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed infants and children with West syndrome 2. Parents willing to participate in trial and follow up at our centre.

Exclusion criteria

Exclusion criteria: 1. Previously treated with Vigabatrin or steroids 2. Severe brain malformations/lethal diseases 3. Contra-indication for steroid use 4. Parents not willing for follow up

Design outcomes

Primary

MeasureTime frame
1. Percentage change in spasm 2. EEG characteristics 3. DASII scores ( neuro-development)Timepoint: At 3 months and 6 months—

Secondary

MeasureTime frame
1. Time to cessation of spasms 2. Rate of recurrence of spasms 3. Influence of other factors on outcomeTimepoint: At 3 months and 6 months—

Countries

India

Contacts

Public ContactDr Kavita Srivastava

Bharati Vidyapeeth Medical College, Pune

kavisri1970@gmail.com9850825791

Outcome results

None listed

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