Status:
UNKNOWN
Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms
Lead Sponsor:
Suvasini Sharma
Conditions:
Infantile Spasm
Eligibility:
All Genders
4-30 years
Phase:
PHASE2
PHASE3
Brief Summary
Infantile Spasms (IS) are classically refractory to the usual antiepileptic drugs and often pose a therapeutic challenge. Since, there is associated significant morbidity, much effort has been directe...
Detailed Description
Multiple studies have subsequently used higher dose of prednisolone in infantile spasms at the weight based dosing of 4-8 mg/kg/day with a maximum dose of 60mg/day. The results have shown high rates o...
Eligibility Criteria
Inclusion
- Newly diagnosed patients aged 4 - 30 months with epileptic spasms in clusters with electroencephalographic evidence of hypsarrhythmia or its variants with or without developmental delay -
Exclusion
- Children with recognized progressive neurological illness will be excluded.
- Children with chronic renal, pulmonary, cardiac or hepatic dysfunction
- Severe malnutrition (weight for length and height for less than 3 SD for mean as per WHO growth charts)
- \-
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2022
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03876444
Start Date
April 1 2019
End Date
October 31 2022
Last Update
November 18 2019
Active Locations (1)
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1
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, India, 110001