Infantile Spasms
Conditions
Keywords
refractory infantile spasms
Brief summary
This is a randomized, controlled study to compare Short-term ketogenic diet with conventional long-term trial in refractory infantile spasms.
Interventions
None listed
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 5 Years
Inclusion criteria
1. Patients, who have recalcitrant infantile spasms and undertake the ketogenic diet at Severance Hospital and Sanggye Paik Hospital from 2005 to 2008. 2. Clinical and electroencephalography findings are compatible with infantile spasms 3. Spasms are intractable to the initial combination of vigabatrin (150 mg/kg) and topiramate (10 mg/kg) and/or additional indicated anti-epileptic drugs including prednisolone (2 mg/kg for 2 weeks and an additional 2 weeks for tapering). 4. Study entry requires magnetic resonance imaging to confirm the absence of a progressive cerebral lesion.
Exclusion criteria
1. Patients who have a history of hyperlipidaemia and underlying metabolic diseases including acute intermittent porphyria, pyruvate carboxylase deficiency, and fatty acid oxidation defects. 2. Patients who have a history of nephrolithiasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measures include seizure relapse and frequency after successful completion of the ketogenic diet. | Finally, 35 patients could be followed up for more than 12 months after successful discontinuation of the diet and then primary outcome will be measured. |
Outcome results
None listed