IRCT20200414047072N2
Recruiting
未知
Comparison of efficacy and safety of corticosteroids and vigabatrin plus corticosteroids in infantile spasm: An open label randomized control trial
The Children's Hospital & the Institute of Child Health, Multan.0 sites320 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Infantile spasm.
- Sponsor
- The Children's Hospital & the Institute of Child Health, Multan.
- Enrollment
- 320
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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