Preora: Prevalence of Oral Disorders in Children in ENT Pathologies

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05909787

Collaborator

(none)

2,000

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders Language Disorders	Other: Auto-questionnaire	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Prevalence of Oral Disorders in Children Identified by Parents in the Context of ENT Pathologies

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Auto-questionnaire MCH (Montreal Children's Hospital) Auto-questionnaire MCH (Montreal Children's Hospital)	Other: Auto-questionnaire MCH (Montreal Children's Hospital) self questionnaire completed by the parents

Arm

Intervention/Treatment

Experimental: Auto-questionnaire MCH (Montreal Children's Hospital)

Auto-questionnaire MCH (Montreal Children's Hospital)

Other: Auto-questionnaire

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

Outcome Measures

Primary Outcome Measures

Difficulty in feeding [50 minutes]
MCH self questionnaire / HME score

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Natacha TEISSIER, PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT05909787

Other Study ID Numbers:

APHP230191
IDRCB: 2023-A00201-44

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Eating disorders

Language disorders

Childhood

Additional relevant MeSH terms:

Language Disorders

Feeding and Eating Disorders

Study Results

No Results Posted as of Jun 18, 2023