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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05164913
Other study ID # SH9H-2019-T12
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date January 1, 2023

Study information

Verified date August 2021
Source Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Contact Ren Zhou
Phone +8615121007303
Email 318281114@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This topic speculates that there is an interaction between family environment and anesthetic drug exposure on children's behavior. Different family environments have different response to anesthetic drug exposure. Children living in a specific family environment may be more susceptible to the effects of anesthetic drugs. People who are susceptible to exposure to narcotic drugs. In order to clarify this hypothesis and discover specific family environment factors that interact with anesthetic drug exposure, this project intends to establish a retrospective cohort study, through hierarchical analysis and other means, to clarify the behavioral changes of children in different family environments after exposure to anesthetic drugs. Provide theoretical support for the safe application of clinical children's anesthetics.


Recruitment information / eligibility

Status Recruiting
Enrollment 1140
Est. completion date January 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria: - Children aged 0-5 who underwent surgery at Shanghai Ninth People's Hospital - Current age is less than 18 years old - No surgical complications such as acute infectious diseases, systemic diseases Exclusion Criteria: - History of neonatal hypoxic ischemic encephalopathy and bilirubin encephalopathy - There are genetic diseases or chromosomal diseases, neurological diseases (including epilepsy, congenital diseases), or a history of head trauma, a history of central nervous system infectious diseases, high fever convulsions, congenital heart disease, tumor diseases, and Patients with blood diseases - People who have autism, attention deficit hyperactivity disorder, or have received behavioral related treatments and interventions - Those who have undergone cardiovascular surgery, neurosurgery, or those with unstable hemodynamics during surgery - Those who cannot be contacted, refused to join the group, the questionnaire information does not match the medical records, or the complete medical records cannot be obtained

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Achenbach Child Behavior Checklist (CBCL)scale
Use the Achenbach Child Behavior Checklist (CBCL)scale to assess children's behavior

Locations

Country Name City State
China Shanghai Ninth People's Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Achenbach Child Behavior Checklist (CBCL)scale sorce(0-100),higher scores mean a worse immediately after the procedure
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