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Preventable Paediatric Trauma - Retrospective Analysis

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ClinicalTrials.gov Identifier: NCT01825343
Recruitment Status : Unknown
Verified April 2013 by Ziv Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 5, 2013
Last Update Posted : April 5, 2013
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital

Brief Summary:

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


Condition or disease
Pediatric Trauma

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Preventable Paediatric Trauma - Retrospective Analysis
Study Start Date : April 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   None Retained
We are looking retrospectively at data already stored on the hospital database. We have no human subjects and will only analyse hospital records. We will not be contacting patients.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825343


Locations
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Israel
Ziv Hospital
Safed, Galilee, Israel, 13100
Sponsors and Collaborators
Ziv Hospital
Investigators
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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
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Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT01825343    
Other Study ID Numbers: ZIV-0005-13
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013
Keywords provided by Ziv Hospital:
fall
burn
road traffic crash
Additional relevant MeSH terms:
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Wounds and Injuries