General Anesthesia/Surgical Exposure on White Matter Development in Children

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurodevelopmental Delay
• Intervention / Treatment: Other: MRI

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

• Study Contact: Name: Lei Zhang; Phone Number: +8618717822662; Email: weiymzhl@126.com
• Study Contact Backup: Name: Ren Zhou; Phone Number: +8615121007303; Email: zhouren77@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiple anesthesia group; Children who underwent more than one general anesthesia procedure between the ages of 0-3 years.	Other: MRI; MRI is used to assess of brain development.
Single anesthesia group; Children who underwent only one general anesthesia procedure between the ages of 0-3 years.	Other: MRI; MRI is used to assess of brain development.
Control group; Children who underwent no general anesthesia procedure between the ages of 0-3 years.	Other: MRI; MRI is used to assess of brain development.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SH9H-2023-T296

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No