Preventable Paediatric Trauma - Retrospective Analysis

Pediatric Trauma Clinical Trial

Official title:

Preventable Paediatric Trauma - Retrospective Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01825343
• Other study ID #: ZIV-0005-13
• Status: Active, not recruiting
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 4, 2013
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2013
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pediatric Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
Israel	Ziv Hospital	Safed	Galilee

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishing exact mechanism of injury	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)	Yes