Disorder of intellectual development, provisional
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 6 months to 5 years old, no gender limit; 2. For the patients with intellectual development disorders, the test results of Gesell scale showed two or more DQ values of 25 <= DQ <= 70; 3. Complete head magnetic resonance examination (including but not limited to MRI, DTI, DWI, etc.) within the last 90 days; 4. Willing to abide by the protocol, and the guardian of the subject voluntarily signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other known motor retardation / disorders; 2. The object of unexplained regression / degradation of motor, language or cognitive function; 3. Patients with serious visual or auditory disorders and cannot cooperate with the assessment; 4. Patients with autism spectrum disorder or tendency (ABC scale score greater than 32 points), skeletal muscle disease, spinal cord disease, peripheral nerve disease, endocrine disease, autoimmune disease, CNS congenital malformations and other serious systemic diseases, blood system diseases and infectious diseases; 5. Patients with chromosomal diseases and genetic metabolic diseases related to PIDD; 6. Patients with severe other organ dysfunction, such as liver and kidney function exceeding the normal value range by 2 times, or although it does not exceed the normal value range by 2 times, the researcher judges that the abnormality has clinical significance; 7. Patients who have had a history of epileptic seizures in the last 90 days; 8. Patients who are allergic to the study drug and its excipients; 9. Patients who have been treated with the same NGF or other neuroprotective agents, or have taken health foods (such as DHA) that have a clear effect on promoting neurodevelopment, and the drug has been discontinued for less than 14 days; 10. Subjects who have participated in clinical trials of other new drugs in the last 90 days; 11. Other situations that the researcher thinks are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gesell developmental diagnostic scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Infant-Junior High School Students' Social Life Abilities Scale;Peabody development motor scale;Electroencephalogram; | — |
Countries
China
Contacts
Children's Hospital Affiliated to Shandong University