Epileptic encephalopathy in children
Conditions
Interventions
ketogenic group:ketogenic diet and present medication treatment
control group:ordinary diet and conventional drug adding
Sponsors
West China Second University Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
0.3 Years to 6 Years
Inclusion criteria
Inclusion criteria: (1) Disease: epileptic encephalopathy. The patient must first be diagnosed with epilepsy according to the diagnostic criteria of the International League Against Epilepsy (ILAE); second, the diagnosis of epileptic encephalopathy should be made, as the following criteria: 1) The developmental condition before the onset of epilepsy is normal or slightly behind, but developmental retardation or regression becomes obvious after the onset of epilepsy; or, 2) Certain types of epileptic encephalopathy syndromes can be diagnosed, including Otawara syndrome, infantile spasms, Dravet syndrome, early infantile migratory partial epilepsy , Early-onset myoclonic encephalopathy, Landau-Kleffner syndrome, Lennox-Gastaut syndrome, early myoclonic encephalopathy, and myoclonic atonic epilepsy. (2) Age: 3 months to 6 years old; gender: unlimited. (3) One, two, three or more antiepileptic drugs have been suitably used, and the therapeutic effect is not satisfactory. Medication failure is defined as: when antiepileptic drugs are reasonably selected and regularly administrated for more than 3 months, any of the following is deemed to be a failure of medication: 1. The frequency of seizures is reduced by less than 50%; 2. The frequency of seizures is reduced by more than 50%, but the EEG or cognitive behavior indicators is not obviously improved or worse; 3. EEG and cognitive behavior indicators are significantly worsened. (4) The patient has not received any ketogenic diet treatment in the past. (5) The guardian agrees to participate in the research and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe digestion, cardiovascular, respiratory, liver, urinary system, or genetic metabolic diseases that are contraindicated with ketogenic diet (such as fatty acid metabolism disorders, etc.), or congenital immune deficiency diseases. (2) Severe vomiting, fever or active period of infectious disease. (3) Severe malnutrition. (4) Patients who have undergone transplantation, stem cell therapy, infusion of allogeneic blood products within half a year, or have hemolytic diseases. (5) Others: including the contraindications listed in Table 2 not specified above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| seizure frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| EEG features;Cognitive development scale;Ketone body status;tolerance and side effects; | — |
Countries
China
Contacts
Public ContactLuo Rong
West China Second University Hospital, Sichuan University
Outcome results
None listed