NCT05909787

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

June 18, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

June 9, 2023

Last Update Submit

June 9, 2023

Conditions

Eating DisordersLanguage Disorders

Keywords

Eating disordersLanguage disordersChildhood

Outcome Measures

Primary Outcomes (1)

  • Difficulty in feeding

    MCH self questionnaire / HME score

    50 minutes

Study Arms (1)

Auto-questionnaire MCH (Montreal Children's Hospital)

EXPERIMENTAL

Auto-questionnaire MCH (Montreal Children's Hospital)

Other: Auto-questionnaire

Interventions

Auto-questionnaireOTHER

MCH (Montreal Children's Hospital) self questionnaire completed by the parents

Auto-questionnaire MCH (Montreal Children's Hospital)

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Refusal of parents/children to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding and Eating DisordersLanguage Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Study Officials

  • Natacha TEISSIER, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natacha TEISSIER, PhD

CONTACT

+331 40 03 53 67natacha.teissier@aphp.fr

Elise CHAUVIN, PhD student

CONTACT

+331 87 46 82 21elise.chauvin@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 18, 2023

Study Start

July 1, 2023

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

June 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share