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NCT05909787 Clinical Trial

Prevalence of Oral Disorders in Children in ENT Pathologies

Eating Disorders Clinical Trial

— Preora  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05909787
Other study ID # APHP230191
Secondary ID IDRCB: 2023-A002
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date November 1, 2023

Study information
Verified date April 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Natacha TEISSIER, PhD
Phone +331 40 03 53 67
Email natacha.teissier@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 2000
Est. completion date November 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Day to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Auto-questionnaire
MCH (Montreal Children's Hospital) self questionnaire completed by the parents

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome
Type Measure Description Time frame Safety issue
Primary Difficulty in feeding MCH self questionnaire / HME score 50 minutes
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