Infantile spasm. Epileptic spasms, not intractable, without status epilepticus
Conditions
Interventions
Intervention 1: Intervention group 1: Children will be divided into two groups by random allocation for the selection of treatment protocol. Group A children will receive prednisolone 40 mg/day in 4 d
Sponsors
The Children's Hospital & the Institute of Child Health, Multan.
Eligibility
Sex/Gender
All
Age
1 Months to 12 Months
Inclusion 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
Exclusion criteria: Infantile spasm due to tuberous sclerosis Previous treatment with steroids or vigabatrin Contraindication to steroids/vigabatrin (fever, active infection and hypertension).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Pakistan
Contacts
Public ContactDr. Nuzhat Noureen
The Children's Hospital & the Institute of Child Health, Multan.
Outcome results
None listed