Neurodevelopmental Delay Clinical Trial
Official title:
A Study of the Effects of General Anesthesia/Surgical Exposure on Distant Cerebral White Matter Development in Children
International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development.
| Status | Not yet recruiting |
| Enrollment | 210 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | November 30, 2026 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 12 Years to 15 Years |
| Eligibility | Inclusion Criteria: - Currently between 12 and 15 years of age Exclusion Criteria: - Surgical complications such as acute infectious diseases, systemic diseases - Abnormal findings on cerebral white matter and/or neurobehavioral assessment - History of neonatal ischemic-hypoxic encephalopathy, bilirubin encephalopathy - Genetic or chromosomal disorders, neurological disorders (including epilepsy, congenital disorders), or a history of craniocerebral trauma, infectious diseases of the central nervous system, febrile convulsions, congenital heart disease, oncological diseases, and blood disorders - Autism, attention deficit hyperactivity disorder, or those who have received behavioral therapy and intervention. - Children with organic damage to the nervous system - Cardiovascular surgery, neurosurgery or intraoperative hemodynamic instability. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MRI-based assessment of brain development | Magnetic resonance scanning of T1-weighted images, T2-weighted images, and diffusion tensor imaging (DTI) of both cerebral hemispheres, looking at whole-brain white matter volume as a percentage of total intracranial volume | one time, through study completion, an average of 3 month |
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