- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01825343
Preventable Paediatric Trauma - Retrospective Analysis
Purpose: a retrospective study of all Paediatric patients who presented to Ziv Medical Centre with injuries of all systems, major and minor, in order to determine the exact circumstances of the injury, whether this might have been preventable and design a Haddon Matrix of risk factors for injury to target prevention.
Hypothesis: injury prevention interventions can be targetted by finding out local causes of Paediatric Trauma
Study Overview
Status
Conditions
Detailed Description
A Trauma Registry is already kept in the hospital. It is confidential and data is supplied to the government from this registry.
The procedure is to be granted access to the database and access data stored on the mechanism and outcome of Paeditric Trauma. This data will be stored on the work computer of the principal investigator and will be password protected.
Methods: Identify from the Trauma database all patients assessed at Ziv Medical Centre with Trauma, consult their medical notes and document the exact injury, the mechanism of injury, the circumstances, whether the child was alone or supervised, the nature and complications of the injury, treatment required and short and long term progress and disability.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Galilee
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Safed, Galilee, Israel, 13100
- Ziv Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients classified as Paediatric according to Israeli law (up to the age of 18 years). This includes pregnant women and patients presenting with multiple complaints as well as Trauma, isolated injuries and polytrauma.
Exclusion Criteria:
- Patients for whom no history is available.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establishing exact mechanism of injury
Time Frame: 5 years (2007-2012)
|
This is a retrospective study.
We approximate that since the Trauma registry began in 2007, there have been 200 Paediatric injuries every year.
By the end of this year's data collection, therefore, we estimate that we would have collected data from 1000 patients.
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5 years (2007-2012)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Wajdi Safadi, MD, Specialist Surgeon
- Study Director: Seema Biswas, FRCS, Specialist Surgeon
- Principal Investigator: Amram Hadary, MD, Senior Surgeon
- Study Chair: Igor Waksman, MD, head of department
- Study Chair: Dudu Fuchs, RN, Ziv Hospital Trauma Coordinator
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZIV-0005-13
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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