General Anesthesia/Surgical Exposure on White Matter Development in Children

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-15
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Currently between 12 and 15 years of age

Disqualifiers

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

Trial population

Age between 12-15 years.Past history doesn't lead to abnormal brain development.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • MRI

    Other intervention

    MRI is used to assess of brain development.

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: Multiple anesthesia group1 intervention
Group B: Single anesthesia group1 intervention
Group C: Control group1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
one time, through study completion, an average of 3 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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