Pediatric Neurological diseases
Conditions
Interventions
Intervention Group:ketogenic diet therapy
Routine Group:Routine treatment
Sponsors
Shenzhen Children's Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: (1) Ketogenic diet was used to prevent epilepsy in preterm or other high risk infants with brain injury, 76 cases in the intervention group and 76 cases in the control group. (2) Early intervention of status epilepticus shortened the length of hospital stay and reduced the sequelae. Ninety-four patients were enrolled in the intervention group and 48 patients in the control group. (3) Early treatment of epileptic encephalopathy to reduce disability, predictive biomarkers, exposed and unexposed 94 cases each. (4) Prevention and early improvement of core symptoms of autism spectrum disorder, intervention and non-intervention 68 cases respectively. (5) Adjuvant treatment of intracranial infection, reduction of complications and sequelae, immunological mechanism, intervention and control of 130 cases each. To explore the standardized treatment process or develop appropriate evaluation methods. Diagnostic criteria: Zhu Futang Practical Pediatrics, 9th edition and updated guideline.The inclusion and exclusion criteria of each subquestion are as follows: 1) Premature infants and other high-risk infants with brain injury inclusion criteria: The inclusion criteria were hospitalized in the department of Neonatology (gestational age < 37 weeks), both male and female, with congenital or acquired brain injury diseases within the age of 2 months, including gene related, structural, metabolic, infectious, immune, etc., or the etiology was unknown. 2) Status epilepticus Inclusion criteria: according to the International League Against Epilepsy 2015 diagnostic criteria, convulsive status epilepticus, age 0-18 years old, regardless of gender. 3)Ketogenic diet as an early adjuvant therapy for epileptic encephalopathy Inclusion criteria: According to the 2017-2022 edition of the International League Against Epilepsy diagnostic classification criteria, newly diagnosed infantile epileptic spasm syndrome (IESS) was untreated, with onset within 2 years of age, of both boys and girls. 4) Ketogenic diet for prevention and early improvement of core symptoms of autism spectrum disorder (ASD) Inclusion criteria: ASD was diagnosed according to the Chinese Expert consensus on the Early diagnosis of ASD in Young children 2022 edition, children under 18 years of age, regardless of gender. 5) Ketogenic diet for intracranial infection: Inclusion criteria: patients were diagnosed with bacterial meningitis according to the expert consensus on the diagnosis and treatment of community-acquired bacterial meningitis in children (2019 edition), with etiological evidence or cerebrospinal fluid WBC over 500*10^6/L, under 18 years old, regardless of gender.
Exclusion criteria
Exclusion criteria: Contraindications to the ketogenic diet: ? Absolute contraindications: carnitine deficiency (mainly primary; Carnitine palmitoyltransferase (CPT) I and II deficiency; Carnitine translocase deficiency; ß-oxidation disorders; Medium-chain acyl dehydrogenase deficiency (MCAD); Long-chain acyl dehydrogenase deficiency (LCAD); Short-chain acyl dehydrogenase deficiency (SCAD); Long-chain 3-hydroxyacyl-coa deficiency; Medium-chain 3-hydroxyacyl-coa deficiency; Pyruvate carboxylase deficiency; Porphyria. ? Relative contraindications: patients who cannot maintain proper nutrition; Uncooperative parents or guardians; Propofol is administered simultaneously (possibly at higher risk for the propofol infusion syndrome, 24 hours apart is recommended). Exclusion criteria for each project as follows: 1) Exclusion criteria for epilepsy in preterm infants and other high-risk infants with brain injury: those diagnosed with neonatal epilepsy or epileptic syndrome within 2 months after birth; Serious heart, lung, liver, kidney and other organs or systemic diseases, life instability or serious dysfunction; Congenital heart disease, affecting cardiac function, and contraindications to ketogenic diet therapy. 2) Ketogenic diet for status epilepticus exclusion criteria: severe heart, lung, liver, kidney and other organ or systemic diseases, unstable life or severe dysfunction; Contraindications to ketogenic diet therapy. 3) Exclusion criteria for early ketogenic diet treatment of epileptic encephalopathy: severe heart, lung, liver, kidney and other organ or systemic diseases, unstable life or severe dysfunction; Contraindications to ketogenic diet therapy. 4) The exclusion criteria for the prevention and early improvement of the core symptoms of ASD were as follows: severe heart, lung, liver, kidney and other organ or systemic diseases, unstable life or severe dysfunction; Patients with contraindications to ketogenic diet therapy; Currently incurable rare diseases that cause autism spectrum disorders. 5) Exclusion criteria in intracranial infection project with adjunct ketogenic diet therapy: severe heart, lung, liver, kidney and other organ or systemic diseases, serious complications, leading to life instability or serious dysfunction; Contraindications to ketogenic diet therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| responder rate of seizures;duration of status epilepticus;rate of EEG epileptiform discharge;rate of efficacy in core symptoms of autism;rate of sequela at 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of adverse event; | — |
Countries
China
Contacts
Public ContactJianxiang Liao
Shenzhen Children's Hospital
Outcome results
None listed