Efficacy and Safety of corticosteroids and vigabatrin plus corticosteroids in infantile spasm
Not Applicable
Recruiting
- Conditions
- Infantile spasm.Epileptic spasms, not intractable, without status epilepticusG40.822
- Registration Number
- IRCT20200414047072N2
- Lead Sponsor
- The Children's Hospital & the Institute of Child Health, Multan.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
Signed informed consent from parents/guardians
Children aged one to 12 months
Both genders with clinical diagnosis of infantile spasm made according to international league against epilepsy plus hypsarrhythmia on EEG (EEG records were graded using the Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system
Exclusion Criteria
Infantile spasm due to tuberous sclerosis
Previous treatment with steroids or vigabatrin
Contraindication to steroids/vigabatrin (fever, active infection and hypertension).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Electroclinical remission (cessation of spasms plus resolution ofhypsarrhythmia). Timepoint: Before intervention and Day 4, 7, 14, 21, 28, 42, 60, 90, 120, 150 and day 180. Method of measurement: Fundoscopy and blood pressure.;EEG will be performed at day 0, 14, 42, 60, 90 and 180. Sleep EEG will be recorded for a minimum duration of 30 minutes according to international 10-20 system of electrode placement. Timepoint: day 0, 14, 42, 60, 90 and 180. Method of measurement: Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system.;Developmental assessment. Timepoint: day 0, 90 and 180. Method of measurement: portage early education program (PEEP).
- Secondary Outcome Measures
Name Time Method