<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03250936</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3058</org_study_id>
    <nct_id>NCT03250936</nct_id>
  </id_info>
  <brief_title>Descriptive Study of Trampoline Accidents in the Pediatric Emergency Department of Rennes</brief_title>
  <acronym>TRAUMPO</acronym>
  <official_title>Descriptive Study of Trampoline Accidents in the Pediatric Emergency Department of Rennes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare trauma related to others sport to trauma due to&#xD;
      trampoline in pediatric emergencies of Rennes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trampoline accidents are increasing since a few years. In Rennes hospital, pediatric&#xD;
      emergencies are experiencing a subjective increase in admissions for trampoline trauma with&#xD;
      increasingly early ages and severe trauma. The aim of this study is to compare trauma related&#xD;
      to others sport to trauma due to trampoline in pediatric emergencies of Rennes.&#xD;
&#xD;
      In parallel, retrospective data analysis will be performed on the same data during the year&#xD;
      2008, to compare with a period before the explosion of trampoline sales.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Actual">January 31, 2017</completion_date>
  <primary_completion_date type="Actual">January 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes.</measure>
    <time_frame>6 months</time_frame>
    <description>Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arguments for preventive management in the general practitioner</measure>
    <time_frame>6 months</time_frame>
    <description>Arguments for preventive management in the general practitioner</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4000</enrollment>
  <condition>Trauma</condition>
  <condition>Emergencies</condition>
  <condition>Child, Only</condition>
  <arm_group>
    <arm_group_label>Trampoline group</arm_group_label>
    <description>Child patients with trauma due to trampoline from june 2016 to december 2016 consulting in emergencies unit of Rennes' hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Child patients with trauma related to sport from june 2016 to december 2016 consulting in emergencies unit of Rennes' hospital</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children between 2 and 16 years old consulting in pediatric emergencies for a trauma&#xD;
        related to trampoline Children between 2 and 16 years old consulting in pediatric&#xD;
        emergencies for a trauma related to others sport&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child from 2 to 16 years old&#xD;
&#xD;
          -  Childs admitted in emergencies unit for a trauma&#xD;
&#xD;
          -  Parents not opposed in their child's participation to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child under 2 years old (before learning to walk)&#xD;
&#xD;
          -  Single wounds and head injuries not related to sports activities (Fall from a bed or&#xD;
             from its height, simple wound with sharp objects)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernard Fraisse, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric and orthopedic surgery division</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>trampoline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03250936
org study id: 35RC16_3058
nct id: NCT03250936
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare trauma related to others sport to trauma due to
      trampoline in pediatric emergencies of Rennes.
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.
observational model: Cohort
time perspective: Prospective
measure: Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes.
time frame: 6 months
description: Types of trauma related to trampoline compared to trauma related to others sport in pediatric emergencies of Rennes.
measure: Arguments for preventive management in the general practitioner
time frame: 6 months
description: Arguments for preventive management in the general practitioner
arm group label: Trampoline group
description: Child patients with trauma due to trampoline from june 2016 to december 2016 consulting in emergencies unit of Rennes' hospital
arm group label: Control group
description: Child patients with trauma related to sport from june 2016 to december 2016 consulting in emergencies unit of Rennes' hospital
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
healthy volunteers: No
last name: Bernard Fraisse, Dr
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies