infantile spasms
Conditions
Interventions
Experimental:specially-formulated very low carbohydrate meals (KD) with meidication
Control group:General diet with routing treatment
Sponsors
Peking University 1st hospital
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of infantile spasm conforms to criteria of ILAE (2001): epileptic spasms, hypsarrhythmia pattern on electroencephalography, delayed motor and mental development; 2. Patients with poor or recurrent outcomes after trying ACTH or corticosteroids for more than 14 days with dosage more than 1.5mg/d. And the medicine has been taken off for more than 14 days; 3. Aged 3-36 months; 4. Seizure frequency (at least 4 cluster per month); 5. No previous treatment with ketogenic diet; 6. The guardian agrees to use ketogenic diet, collect blood samples from patents for sequencing analysis and sign a consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with severe digestive, cardiovascular, respiratory, urinary, liver or genetic metabolic disease, and congenital immunodeficiency disease; 2. Severe vomiting; 3. Active stage of febrile or infectious diseases; 4. Metabolic disease contraindicating use of the ketogenic diet e.g. pyruvate carboxylase deficiency, Pyruvate carboxylase de?ciency, porphyria, long-chain acyl dehydrogenase de?ciency (LCAD), medium-chain acyl dehydrogenase deficiency (MCAD) from previous medical investigation and screening at baseline; 5. Severe food refusal; 6. Patients who had undergone transplantation, stem cell therapy and transfused allogeneic blood products within half a year and the patients have hemolytic disease; 7. Definite surgical focus was identified and the patient has indications for the surgical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure Frequency; | — |
Countries
China
Contacts
Public ContactWu Ye
Peking University 1st hospital
Outcome results
None listed