<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/NCT04482218</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0391</org_study_id>
    <nct_id>NCT04482218</nct_id>
  </id_info>
  <brief_title>Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations</brief_title>
  <acronym>EDEN</acronym>
  <official_title>Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the New HAS 2019 Recommendations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Undernutrition is a widely under-diagnosed public health problem, including in pediatrics&#xD;
      department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.&#xD;
&#xD;
      Until now, there has been no national consensus on the criteria to be used to diagnose&#xD;
      paediatric undernutrition. Until now, assessment focused on a range of non-consensus&#xD;
      arguments that allowed the health care team to make its diagnosis. So, in the absence of&#xD;
      well-defined criteria, diagnosis was based in part on experience and assesment team.&#xD;
&#xD;
      Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has&#xD;
      suggested recommendations to standardize pediatric undernutrition diagnosis.&#xD;
&#xD;
      The investigators offer to evaluate undernutrition prevalence differences diagnosed according&#xD;
      to new HAS criteria compared to the previous diagnostic methodology.&#xD;
&#xD;
      The investigator's secondary aim is to identify profiles of children who do match between the&#xD;
      two diagnostics methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a prospective cohort without change in care.&#xD;
&#xD;
      Following classic patient admission in involved departments, the investigating team moves to&#xD;
      the department to collect data.&#xD;
&#xD;
      The measurements and informations collected are no different from those taken in the context&#xD;
      of normal care.&#xD;
&#xD;
      All anthropometric measurements correspond to recommendations of good practice.&#xD;
      Anthropometric measurements will be carried out by the healthcare team.&#xD;
&#xD;
      With collected data the investigators will evaluate undernutrition for each child, according&#xD;
      to the 2 diagnostics methods.&#xD;
&#xD;
      For any diagnosis of undernutrition, the department dietician will be alerted so that the&#xD;
      patient can be taken care of so it is done normally.&#xD;
&#xD;
      Data collected are as follows:&#xD;
&#xD;
      Simple demographic characteristics: Age, sex, departmentsand principal diagnosis&#xD;
      Anthropometry: weight, height, brachial perimeter, head circumference Birth weight and date&#xD;
      of term of pregnancy. Clinical history: all pathologies or clinical events that may be&#xD;
      related to a weight variation.&#xD;
&#xD;
      Assessment of ingesta. A non-opposition will be asked&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology</measure>
    <time_frame>2 month</time_frame>
    <description>Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identified profiles of children who do match between the two diagnostics methods</measure>
    <time_frame>2 month</time_frame>
    <description>Identified profiles of children who do match between the two diagnostics methods</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Undernutrition</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children under 18 admitted for hospitalization in the pediatric deparment of the&#xD;
        Montpellier University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patient under 18 years old (HAS 2019)&#xD;
&#xD;
          -  Patient admitted to short and long-stay pediatric services at Montpellier University&#xD;
             Hospital, other than maternity, neonatal, palliative care or resuscitation and&#xD;
             rehabilitation department.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Parental or child opposition&#xD;
&#xD;
          -  Legal guardian unable to express consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoine AVIGNON, PR</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Antromopemtric data</keyword>
  <keyword>Pediatry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </patient_data>
  <!-- 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/NCT04482218
org study id: RECHMPL20_0391
nct id: NCT04482218
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Undernutrition is a widely under-diagnosed public health problem, including in pediatrics
      department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.

      Until now, there has been no national consensus on the criteria to be used to diagnose
      paediatric undernutrition. Until now, assessment focused on a range of non-consensus
      arguments that allowed the health care team to make its diagnosis. So, in the absence of
      well-defined criteria, diagnosis was based in part on experience and assesment team.

      Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has
      suggested recommendations to standardize pediatric undernutrition diagnosis.

      The investigators offer to evaluate undernutrition prevalence differences diagnosed according
      to new HAS criteria compared to the previous diagnostic methodology.

      The investigator's secondary aim is to identify profiles of children who do match between the
      two diagnostics methods.
The investigators will conduct a prospective cohort without change in care.

      Following classic patient admission in involved departments, the investigating team moves to
      the department to collect data.

      The measurements and informations collected are no different from those taken in the context
      of normal care.

      All anthropometric measurements correspond to recommendations of good practice.
      Anthropometric measurements will be carried out by the healthcare team.

      With collected data the investigators will evaluate undernutrition for each child, according
      to the 2 diagnostics methods.

      For any diagnosis of undernutrition, the department dietician will be alerted so that the
      patient can be taken care of so it is done normally.

      Data collected are as follows:

      Simple demographic characteristics: Age, sex, departmentsand principal diagnosis
      Anthropometry: weight, height, brachial perimeter, head circumference Birth weight and date
      of term of pregnancy. Clinical history: all pathologies or clinical events that may be
      related to a weight variation.

      Assessment of ingesta. A non-opposition will be asked
observational model: Cohort
time perspective: Prospective
measure: Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology
time frame: 2 month
description: Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology
measure: Identified profiles of children who do match between the two diagnostics methods
time frame: 2 month
description: Identified profiles of children who do match between the two diagnostics methods
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 18 Years
healthy volunteers: No
last name: Antoine AVIGNON, PR
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Malnutrition
sharing ipd: Undecided
ipd description: NC