Health Condition 1: G408- Other epilepsy and recurrent seizures Health Condition 2: G408- Other epilepsy and recurrent seizures
Conditions
Interventions
Intervention1: LEVETIRACETAM: 20mg/kg/day BD for 6 months
Control Intervention1: SODIUM VALPROATE: 20 mg/kg/day BD for 6 months
Sponsors
Maharani Laxmi Bai Medical College Jhansi Uttar Pradesh India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children with age group of months to 5 years 2. Febrile status epilepticus 3. First episode of Complex Febrile seizure with risk factor 4. Informed consent from parents OR guardians 5. Diagnosed with frequent Complex febrile seizure
Exclusion criteria
Exclusion criteria: 1.Prior unprovoked seizure afebrile OR diagnosed case of epilepsy 2.Patient already on any ASM medication before enrollment 3.Patient known case of CNS congenital abnormalities or CNS infection. 4.Patients with known case of hypersensitivity reaction to levetiracetam or sodium valproate 5.Derranged baseline liver function test , thrombocytopenia at baseline or dyselectrolytemia 6. Any comorbidity making participant unsafe as per investigator judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of children experiencing more than 1 recurrence of complex febrile seizure after initiation of prophylaxis.Timepoint: Within 6 months of follow-up after enrollment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration from initiation of prophylaxis to first breakthrough febrile seizure. 2. Clinical or laboratory adverse effects (irritability, somnolence, behavioral changes, gastrointestinal symptoms, thrombocytopenia, elevated liver enzymes). 3. Proportion of children maintaining prescribed prophylaxis regimen. 4. Association of factors (age 18 months, family history of febrile seizures or epilepsy, neurodevelopmental delay, number of prior seizures) with recurrence.Timepoint: 1. Time to first seizure recurrence (within 6 months). 2. Incidence of adverse drug reactions (1, 3 & 6 months). 3. Treatment adherence or compliance (1, 3 & 6 months). 4. Predictors of seizure recurrence (at 6 months). | — |
Countries
India
Contacts
Public ContactDr. Nupur Pandey
MAHARANI LAXMI BAI MEDICAL COLLEGE
Outcome results
None listed