TraumaTRAUMPONCT03250936
Descriptive Study of Trampoline Accidents in the Pediatric Emergency Department of Rennes
An observational study of Trauma and Emergencies, run by Rennes University Hospital at 1 site in France.
Trial summary
The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Trauma, Emergencies, Child, Only
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2016to 31 Jan 2017
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between 2 and 16 years old consulting in pediatric emergencies for a trauma related to trampoline Children between 2 and 16 years old consulting in pediatric emergencies for a trauma related to others sport
Who may be able to join
- Child from 2 to 16 years old
- Childs admitted in emergencies unit for a trauma
- Parents not opposed in their child's participation to the study
Who cannot join
- Child under 2 years old (before learning to walk)
- Single wounds and head injuries not related to sports activities (Fall from a bed or from its height, simple wound with sharp objects)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes.
Read the detailed description
Trampoline accidents are increasing since a few years. In Rennes hospital, pediatric emergencies are experiencing a subjective increase in admissions for trampoline trauma with increasingly early ages and severe trauma. The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes.
In parallel, retrospective data analysis will be performed on the same data during the year 2008, to compare with a period before the explosion of trampoline sales.
- Conditions
- Trauma, Emergencies, Child, Only
- Keywords
- trampoline
- Medical subject headings
- Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Trampoline group | Child patients with trauma due to trampoline from june 2016 to december 2016 consulting in emergencies unit of Rennes' hospital | |
| Control group | Child patients with trauma related to sport from june 2016 to december 2016 consulting in emergencies unit of Rennes' hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes.
Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes.
Measured: 6 months
Secondary outcomes (1)
Arguments for preventive management in the general practitioner
Arguments for preventive management in the general practitioner
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start6 Dec 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Fraisse, Dr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250936
- Sponsor's protocol ID
- 35RC16_3058
- Acronym
- TRAUMPO
- Status last verified
- Aug 2017
- First submitted
- 11 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Trampoline Accidents in the Pediatric Emergency Department of Rennes
- ClinicalTrials.gov ID
- NCT03250936
- Acronym / sponsor ID
- TRAUMPO / 35RC16_3058
- Conditions
- Trauma, Emergencies, Child, Only
- Keywords
- trampoline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 16 Aug 2017 (actual)
- 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.
The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes.
Detailed description
Trampoline accidents are increasing since a few years. In Rennes hospital, pediatric emergencies are experiencing a subjective increase in admissions for trampoline trauma with increasingly early ages and severe trauma. The aim of this study is to compare trauma related to others sport to trauma due to trampoline in pediatric emergencies of Rennes.
In parallel, retrospective data analysis will be performed on the same data during the year 2008, to compare with a period before the explosion of trampoline sales.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trampoline group | – | –Child patients with trauma due to trampoline from june 2016 to december 2016 consulting in emergencies unit of Rennes' hospital |
| Control group | – | –Child patients with trauma related to sport from june 2016 to december 2016 consulting in emergencies unit of Rennes' hospital |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between 2 and 16 years old consulting in pediatric emergencies for a trauma related to trampoline Children between 2 and 16 years old consulting in pediatric emergencies for a trauma related to others sport
Key inclusion criteria (3 listed)
- Child from 2 to 16 years old
- Childs admitted in emergencies unit for a trauma
- Parents not opposed in their child's participation to the study
Key exclusion criteria (2 listed)
- Child under 2 years old (before learning to walk)
- Single wounds and head injuries not related to sports activities (Fall from a bed or from its height, simple wound with sharp objects)
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
Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes.
Time frame: 6 months
Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes.
1 secondary outcome
Arguments for preventive management in the general practitioner
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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.
Bernard Fraisse, Dr principal investigator
Rennes University Hospital
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 Trauma and Emergencies, run by Rennes University Hospital at 1 site in France.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 29 Aug 2017. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes. (time frame: 6 months). 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 29 Aug 2017.