- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04528810
A Study of Child Injury Based on Data Mining
October 25, 2022 updated by: Children's Hospital of Fudan University
A Prospective Observational Study of Child Injury Based on Data Mining
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
10762
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: YANG CHEN
- Phone Number: +8613918374679
- Email: chenyangcn@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
pediatric patients between the ages of 0-18 years newly diagnosed with injuries
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Child injuries
pediatric patients under the age of 18 years newly diagnosed with injuries in the emergency department
|
This is an observational study and does not include interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distribution of injury categories
Time Frame: At baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28 days mortality
Time Frame: Within 28 days from ED admission
|
Mortality within 28 days from Emergency Department(ED)admission based on electronic medical records system
|
Within 28 days from ED admission
|
180 days mortality
Time Frame: Within 180 days from ED admission
|
Mortality based on electronic medical records system
|
Within 180 days from ED admission
|
Short-term disability
Time Frame: At 180 days from ED admission
|
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
|
Percentage of ICU admission
Time Frame: From ED admission to 72 hours
|
Percentage of ICU admission from ED admission to 72 hours based on electronic medical records system
|
From ED admission to 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
August 25, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
August 27, 2020
Study Record Updates
Last Update Posted (Actual)
October 26, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHFU20200816
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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