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Prevalence of Oral Disorders in Children in ENT Pathologies (Preora)

Primary Purpose

Eating Disorders, Language Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auto-questionnaire
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eating Disorders focused on measuring Eating disorders, Language disorders, Childhood

Eligibility Criteria

1 Day - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients consulting at ENT departement Robert Debré Hospital Age 0-17 years Parents and children informed and given their oral consent for the study and speaking french Exclusion Criteria: Refusal of parents/children to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Auto-questionnaire MCH (Montreal Children's Hospital)

    Arm Description

    Auto-questionnaire MCH (Montreal Children's Hospital)

    Outcomes

    Primary Outcome Measures

    Difficulty in feeding
    MCH self questionnaire / HME score

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2023
    Last Updated
    June 9, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05909787
    Brief Title
    Prevalence of Oral Disorders in Children in ENT Pathologies
    Acronym
    Preora
    Official Title
    Prevalence of Oral Disorders in Children Identified by Parents in the Context of ENT Pathologies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Many children have eating and verbal oral disorders. Our research entitled: PREORA aims to study the prevalence of oral disorders presented in children consulting in ENT department for three months (n = 2000). This first study will be carried out by passing the MCH (Montreal Children's Hospital) feeding scale, a self-questionnaire completed by the parents, in order to assess the presence of disorders according to the parents and will allow us to present oral disorders (Score > 70).
    Detailed Description
    Over a period of inclusion of 3 months, the doctors of the departement ONT, Robert Debré Hospital, will give written and oral information to the holders of parental authority and to the child at the beginning of the consultation. After a 15-minute reflection period (consultation time), if they agree to participate, parents will answer the doctor's questions and then complete the self-questionnaire.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorders, Language Disorders
    Keywords
    Eating disorders, Language disorders, Childhood

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Auto-questionnaire MCH (Montreal Children's Hospital)
    Arm Type
    Experimental
    Arm Description
    Auto-questionnaire MCH (Montreal Children's Hospital)
    Intervention Type
    Other
    Intervention Name(s)
    Auto-questionnaire
    Intervention Description
    MCH (Montreal Children's Hospital) self questionnaire completed by the parents
    Primary Outcome Measure Information:
    Title
    Difficulty in feeding
    Description
    MCH self questionnaire / HME score
    Time Frame
    50 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients consulting at ENT departement Robert Debré Hospital Age 0-17 years Parents and children informed and given their oral consent for the study and speaking french Exclusion Criteria: Refusal of parents/children to participate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Natacha TEISSIER, PhD
    Phone
    +331 40 03 53 67
    Email
    natacha.teissier@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elise CHAUVIN, PhD student
    Phone
    +331 87 46 82 21
    Email
    elise.chauvin@aphp.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Natacha TEISSIER, PhD
    Organizational Affiliation
    Assistance Publique - Hôpitaux de Paris
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prevalence of Oral Disorders in Children in ENT Pathologies

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