Preventable Paediatric Trauma - Retrospective Analysis

April 4, 2013 updated by: Ziv Hospital

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

Unknown

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

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Galilee
      • Safed, Galilee, Israel, 13100
        • Ziv Hospital

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

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: 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.
5 years (2007-2012)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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

April 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 4, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

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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