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Oral dexamethasone versus prednisolone in west syndrome

Oral dexamethasone versus prednisolone for management of children with west syndrome: An open labelled randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032533
Enrollment
40
Registered
2021-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: G94- Other disorders of brain in diseases classified elsewhere

Interventions

Intervention1: Dexamethasone: Oral dexamethasone (0.6 mg/kg/day) in four divided doses for 14 days Control Intervention1: Prednisolone: Oral prednisolone (4 mg/kg/day) in two divided doses for 14 days

Sponsors

Narain Das Vaswani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed children aged 3-36 months with West syndrome

Exclusion criteria

Exclusion criteria: 1. Children with recognized progressive neurological illness 2. Children with renal, pulmonary, cardiac or hepatic dysfunction 3. Children with severe malnutrition as per World Heath Organization criteria

Design outcomes

Primary

MeasureTime frame
Primary electroclinical remissionTimepoint: Baseline 2 weeks—

Secondary

MeasureTime frame
1. Spasm cessation 2. Greater than 50% reduction in spasm frequency 3. Greater than 90% reduction in spasm frequency 4. Resolution of hypsarrhythmiaTimepoint: Baseline 2 Weeks—

Countries

India

Contacts

Public ContactMonica Deswal

Pt B D Sharma Postgraduate Institute of Medical Sciences

ndvaswani@hotmail.com9034428284

Outcome results

None listed

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