A clinical trial to compare two different doses of Prednisolone in the management of children with West syndrome
Phase 4
- Conditions
- Health Condition 1: G408- Other epilepsy and recurrent seizures
- Registration Number
- CTRI/2021/09/036739
- Lead Sponsor
- PtBD Sharma Post Graduate Institute of Medical Sciences Rohtak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Newly diagnosed children aged 3-36 months with West syndrome
Exclusion Criteria
1.children with recognised progressive
neurological illness.
2.children with renal, pulmonary,cardiac or hepatic dysfunction.
3.severe malnutrition (weight for length and height for less than 3 SD for mean as per WHO growth charts.
4.Those screened positive for mantoux test( >10mm).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Electroclinical remission at 2 weeks of treatmentTimepoint: 2 weeks
- Secondary Outcome Measures
Name Time Method 1-50% reduction in spasms at 2 weeks of treatment <br/ ><br>2-safety of high dose and very high dose Prednisolone in terms of proportion of children with parent reported side effects.Timepoint: 2 weeks