A Randomized Controlled Study of Mouse Nerve Growth Gactor for Injection in The Treatment of Children With Global Developmental Delay

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200063635

Enrollment

Unknown

Registered

2022-09-13

Start date

2022-08-31

Completion date

Unknown

Last updated

2023-04-17

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

Conditions

Global Developmental Delay (GDD)

Interventions

therapy group:Vitamin D3 800 units/day orally + rehabilitation training + rat nerve growth factor 18ug/time intramuscular injection (use for 10 days and stop for 5 days)

control group:Vitamin D3 800 units/day orally + rehabilitation training

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 0~5 years, gender is not limited; 2. There is evidence that GDD, Griffiths Developmental Assessment Scale-Chinese version (GDS-C) test results total developmental quotient < 70 points; 3. Serum 25(OH)D level below 30 ng/mL.

Exclusion criteria

Exclusion criteria: 1. Unexplained regression/degeneration of motor, language, or cognitive function; 2. Those with severe visual or hearing impairment who cannot cooperate with the assessment; 3. Patients with skeletal muscle disease, spinal cord disease, peripheral nerve disease, chromosomal disease, genetic metabolic disease, endocrine disease, autoimmune disease and other serious systemic diseases, blood system diseases, infectious diseases; 4. Serious abnormality of other organ functions, such as liver and kidney function exceeding 2 times of the normal range, or those who have not exceeded 2 times the normal range but the investigator judges that the abnormality is clinically significant; EEG has epileptiform discharges or diagnosis epilepsy; 5. Those who are allergic to mouse nerve growth factor and excipients; 6. Those who received the same type of mNGF or other neuroprotective agents for less than 14 days after the drug withdrawal; 7. Those who have participated in clinical trials of other new drugs within the last 90 days; 8. Others considered by the researcher should not participate in this researcher.

Design outcomes

Secondary

Measure	Time frame
The Autism Behavior Checklist;Childhood Autism Rating Scale;Clinical efficacy global scale;	—

Primary

Measure	Time frame
Griffiths Developmental Assessment Scale-Chinese Version;	—

Countries

China

Contacts

Public ContactFeiYong Jia

The First Hospital of Jilin University

shanling@jlu.edu.cn+86 13943003914

Outcome results

None listed

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