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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04528810
Other study ID # CHFU20200816
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2024

Study information

Verified date October 2022
Source Children's Hospital of Fudan University
Contact YANG CHEN
Phone +8613918374679
Email chenyangcn@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A comprehensive pediatric injury burden assessment is an essential foundation for formulating injury prevention strategies and improving emergency care for injured children. Although the hospital-based passive surveillance of national injury surveillance system of medical and health institutions has been well-established in China, the monitoring points of hospitals were not stratified according to children's hospital. Aim of the project is to collect epidemiological and clinical data to describe causes, clinical features and outcomes of pediatric injuries at a Children's Hospital in Shanghai, China. The project intends to establish a method for collecting and analyzing high quality data of child injury using data mining based on the hospital information system.


Description:

Injuries are a leading cause of death for infants and children around the world. According to the Haddon Injury Control Model, 90 percent of injuries are both predictable and preventable. Injuries are preventable, not "accidents". All unintentionally and intentionally injured children first visit to the emergency department are recruited in the study. Children's Hospital of Fudan University with a Regional Pediatric Trauma Centre is also the first Pediatric Injury Prevention Center established in China. We conduct a prospective cohort study to investigate the epidemiology, clinical course, and outcomes of the injured child first visit to the emergency department, which expected to serve as evidence of injury prevention and promising practices. In the study, we collect and analyze high quality data of child injury based on data mining.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10762
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility Inclusion Criteria: All pediatric patients between the ages of 0-18 years newly diagnosed with injuries in the emergency department,and recorded ICD-10 diagnosis codes from V01 to X39 Exclusion Criteria: Patients who were dead on arrival to the emergency department are not included.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
not applicable (Observational Study)
This is an observational study and does not include interventions.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Fudan University

Outcome

Type Measure Description Time frame Safety issue
Primary Distribution of injury categories According to the electronic medical record system, the distribution of injury categories is defined as the proportion of various injury causes (fall,motor vehicle crash,sports, struck, foreign body) in the cohort subjects. At baseline
Secondary 28 days mortality Mortality within 28 days from Emergency Department(ED)admission based on electronic medical records system Within 28 days from ED admission
Secondary 180 days mortality Mortality based on electronic medical records system Within 180 days from ED admission
Secondary Short-term disability Disability accessed by the Glasgow Outcome Scale (GOS) at 180 days from ED admission. The Glasgow Outcome Scale was dichotomized into favorable outcome (moderate disability or good recovery ; GOS score of 4 or 5) and unfavorable outcome (death, vegetative state or severe disability; GOS score 1-3). At 180 days from ED admission
Secondary Percentage of ICU admission Percentage of ICU admission from ED admission to 72 hours based on electronic medical records system From ED admission to 72 hours
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