Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 9 months to 5 years with Infantile spasm refractory to first line treatment.
Exclusion criteria
Exclusion criteria: (i) Children with known or suspected inborn error of metabolism. (ii) Children with systemic illness-renal, pulmonary, cardiac or hepatic dysfunction. (iii) Severe malnutrition (weight for length and height for age less than 3 SD for mean as per WHO growth charts). (iv) Motivational and psychosocial issues in the family which could possibly affect the compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children who achieved seizure freedom as per parental reports at 4 weeks and 12 weeks in both the groups.Timepoint: Proportion of children who achieved seizure freedom as per parental reports at 4 weeks and 12 weeks in both the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Proportion of children who achieved 50 percent reduction in seizure as per parental reports at 4 weeks and 12 weeks in both the groups. b. Proportion of children who achieve resolution of Hypsarrhythmia. c. Description and proportion of the adverse effects of the diet as per parental reports. Timepoint: 4 weeks 12 weeks | — |
Countries
India
Contacts
Pt. B.D. Sharma PGIMS Rohtak