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A multi-center randomized controlled study of mouse nerve growth factor for injection in the treatment of children with motor developmental delay

A multi-center randomized controlled study of mouse nerve growth factor for injection in the treatment of children with motor developmental delay

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025720
Enrollment
Unknown
Registered
2019-09-06
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-09-09

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

Conditions

motor developmental delay

Interventions

control group2:Rehabilitation
experimental group:Rehabilitation+ mouse nerve growth factor injection
control group1:mouse nerve growth factor injection
blank control group:Nothing

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Male or female aged 0 ~6 months; (2) Clinical diagnosis of motor developmental delay; (3) Gross motor function classification system grade is I~ V; (4) Willingness to submit to this experimental scheme, subject guardians voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Obvious postural abnormalities or limb dyskinesia, or diagnosed cerebral palsy; (2) Diagnosed grobal developmental delay; (3) Severe visual or hearing impairment, focal neurological signs; (4) Typical chromosome diseases, genetic metabolic diseases, congenital metabolic defects, endocrine diseases, CNS congenital malformation, neuromuscular diseases, skeletal diseases, etc; (5) Unexplained regression/degeneration of motor, language or cognitive functions; (6) Diagnosed with autism, or autistic traits that can lead to disruptive behavior; (7) Combined epilepsy: previous history of seizures (convulsions), electroencephalogram indicated abnormal discharge; (8) Severe congenital heart disease or clinically significant electrocardiographic abnormalities; (9) Liver and kidney function exceeded the normal range by 2 times, or the researcher judged that the abnormality was clinically significant although it was not beyond the normal range by 2 times; (10) Suffering from other serious systemic diseases, diseases of the blood system or infectious diseases; (11) Allergic to mouse nerve growth factor; (12) Oral, intramuscular or intrathecal injection of drugs and surgical treatment to reduce muscle tension during 6 months before the study and during the experimental study or follow-up period; (13) Patients who received similar NGF or other neuroprotective agents, such as vitamin B1, vitamin B12, mecobalamine, ganglioside, and cerebroprotein hydrolysate, stopped taking the drug for less than 14 days; (14) Who have participated in other new drug clinical trials in the last 3 months; (15) Other reason the researcher considered not suite for research.

Design outcomes

Primary

MeasureTime frame
Gross Motor Function Measure, GMFM-88;Gross Motor Function Classification System, GMFCS;Fine Motor Function Measure, FMFM;Gesell Developmental Schedules;

Countries

China

Contacts

Public ContactYuxia Chen

Children's Hospital of Chongqing Medical University

15023183900@163.com+86 15023183900

Outcome results

None listed

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