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A Multicenter Observational Study of Rehabilitation Training Combined with Mouse Nerve Growth Factor for Injection in The Treatment of Children With Provisional Intellectual Development Disorders by Different Pathogenic Factors

A Multicenter Observational Study of Rehabilitation Training Combined with Mouse Nerve Growth Factor for Injection in The Treatment of Children With Provisional Intellectual Development Disorders by Different Pathogenic Factors

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200056223
Enrollment
Unknown
Registered
2022-02-01
Start date
2022-03-01
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of intellectual development, provisional

Interventions

Prenatal factor group:Rehabilitation training+Mouse nerve growth factor for injection
Intrapartum factor group:Rehabilitation training+Mouse nerve growth factor for injection
Postpartum factor group:Rehabilitation training+Mouse nerve growth factor for injection
Unknown pathogenic factor group:Rehabilitation training+Mouse nerve growth factor for injection
Multiple pathogenic factor group:Rehabilitation training+Mouse nerve growth factor for injection

Sponsors

Children's Hospital Affiliated to Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Gesell developmental diagnostic scale;

Secondary

MeasureTime frame
Infant-Junior High School Students' Social Life Abilities Scale;Peabody development motor scale;Electroencephalogram;

Countries

China

Contacts

Public ContactYan Huang

Children's Hospital Affiliated to Shandong University

jnhuangyan@163.com+86 18866115567

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026