Pediatric TraumaNCT01825343
Preventable Paediatric Trauma - Retrospective Analysis
An observational study of Pediatric Trauma, run by Ziv Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Trauma
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients for whom no history is available.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Pediatric Trauma
- Keywords
- fall, burn, road traffic crash
- Medical subject headings
- Burns
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years (2007-2012)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wajdi Safadi, MD, Study chair, Specialist SurgeonSeema Biswas, FRCS, Study director, Specialist SurgeonAmram Hadary, MD, Principal investigator, Senior SurgeonIgor Waksman, MD, Study chair, Head of DepartmentDudu Fuchs, RN, Study chair, Ziv Hospital Trauma Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825343
- Sponsor's protocol ID
- ZIV-0005-13
- Status last verified
- Apr 2013
- First submitted
- 2 Apr 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventable Paediatric Trauma - Retrospective Analysis
- ClinicalTrials.gov ID
- NCT01825343
- Acronym / sponsor ID
- ZIV-0005-13
- Conditions
- Pediatric Trauma
- Keywords
- fall, burn, road traffic crash
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients for whom no history is available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wajdi Safadi, MD study chair
Specialist Surgeon
Seema Biswas, FRCS study director
Specialist Surgeon
Amram Hadary, MD principal investigator
Senior Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Trauma, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishing exact mechanism of injury (time frame: 5 years (2007-2012)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2013.