Prevalence of Oral Disorders in Children in ENT Pathologies | NCT05909787

Studies
Prevalence of Oral Disorders in Children in ENT Pathologies

NCT05909787

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Jun 18, 2023Actual

Enrollment

2,000Estimated

Phase

Not Applicable

Conditions

Eating Disorders
Language Disorders

Interventions

Auto-questionnaire

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IDRCB: 2023-A00201-44	Registry Identifier	French Health Authority

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Estimated

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Nov 1, 2023Estimated

First Submitted Date

Jun 9, 2023

First Submission Date that Met QC Criteria

Jun 9, 2023

First Posted Date

Jun 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2023

Last Update Posted Date

Jun 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Auto-questionnaire MCH (Montreal Children's Hospital)	Experimental	Auto-questionnaire MCH (Montreal Children's Hospital)	Other: Auto-questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auto-questionnaire	Other	MCH (Montreal Children's Hospital) self questionnaire completed by the parents	Auto-questionnaire MCH (Montreal Children's Hospital)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difficulty in feeding	MCH self questionnaire / HME score	50 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Natacha TEISSIER, PhD	Contact	+331 40 03 53 67		natacha.teissier@aphp.fr
Elise CHAUVIN, PhD student	Contact	+331 87 46 82 21		elise.chauvin@aphp.fr

Overall Officials

Name	Affiliation	Role
Natacha TEISSIER, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001068	Feeding and Eating Disorders
D007806	Language Disorders

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

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Browse Branches

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