Temporary intellectual developmental disability in children
Conditions
Interventions
Cerebroprotein hydrolysate for injection (I) + brain peptide group:Cerebroprotein hydrolysate for injection (I) + brain polypeptide group: The use of cerebroprotein hydrolysate (I) for injection is 10
control group:with conventional basic treatment only
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
0.5 Years to 3 Years
Inclusion criteria
Inclusion criteria: 1. The subject's guardian voluntarily signed the informed consent; 2. Aged 6-36 months, regardless of gender; 3. Diagnosed as temporary intellectual developmental disorder (disease code 6A00.4 in ICD-11); 4. There is evidence of intellectual developmental disability, and the DQ value of the Gesell Developmental Diagnostic Scale test result is 25 <= DQ <= 70.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to cerebroprotein hydrolysate preparations for injection; 2. Those who have used neuroprotective drugs (such as mouse neurotrophic factor, ganglioside, etc.) within 14 days before enrollment or have a clear effect on promoting neurodevelopment; 3. Obvious abnormal posture or limb movement disorder, or diagnosed cerebral palsy; 4. Known to have other motor retardation/disorder diseases, unexplained motor, language or cognitive function regression/degenerative phenomena, autism spectrum disorders, musculoskeletal disorders, spinal cord disorders, peripheral nerve disorders, chromosomal disorders, genetic metabolic disorders, endocrine disorders, autoimmune disorders, CNS congenital malformations, other serious systemic disorders, hematologic disorders; 5. Patients with epileptiform discharge or epilepsy on EEG; 6. Those who have participated in clinical trials of other new drugs within the past 90 days; 7. Those who are considered unsuitable for participating in this experiment by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Developmental Quotient (DQ) assessed by the modified Gesell Developmental Diagnostic Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Infant-Junior High School Student Social Ability Scale (S-M);electroencephalogram (EEG);Head MRi; | — |
Countries
China
Contacts
Public ContactWu De
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed