General Anesthesia/Surgical Exposure on White Matter Development in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neurodevelopmental Delay

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

* 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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No