Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367062
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
General AnesthesiaSurgical Exposure on White Matter Development in Children
Sponsor:
Shanghai Ninth Peoples Hospital Affiliated to Shanghai Jiao Tong University
Organization:
Shanghai Ninth Peoples Hospital Affiliated to Shanghai Jiao Tong University
Study Overview
Official Title:
A Study of the Effects of General AnesthesiaSurgical Exposure on Distant Cerebral White Matter Development in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 applicants 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 childrens brain white matter and related neuropsychological development
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None