EDEN: Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the HAS Recommendations

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04482218
Collaborator
(none)
100
1
2.5
40.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the New HAS 2019 Recommendations
    Actual Study Start Date :
    Jul 17, 2020
    Actual Primary Completion Date :
    Sep 1, 2020
    Actual Study Completion Date :
    Sep 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology [2 month]

      Comparison between HAS 2019 undernutrition criteria and previous diagnostic methodology

    Secondary Outcome Measures

    1. Identified profiles of children who do match between the two diagnostics methods [2 month]

      Identified profiles of children who do match between the two diagnostics methods

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Patient under 18 years old (HAS 2019)

    • Patient admitted to short and long-stay pediatric services at Montpellier University Hospital, other than maternity, neonatal, palliative care or resuscitation and rehabilitation department.

    Exclusion criteria:
    • Parental or child opposition

    • Legal guardian unable to express consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Antoine AVIGNON, PR, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04482218
    Other Study ID Numbers:
    • RECHMPL20_0391
    First Posted:
    Jul 22, 2020
    Last Update Posted:
    Dec 29, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 29, 2020