Otologic and Rhinologic Outcomes in Children With Clef Pa... | NCT03708406

Studies
Otologic and Rhinologic Outcomes in Children With Clef Palate

NCT03708406

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Mar 10, 2020Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Cleft Lip and Palate

Interventions

Not provided

Countries

France

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

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2018Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Oct 8, 2018

First Submission Date that Met QC Criteria

Oct 16, 2018

First Posted Date

Oct 17, 2018Actual

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

Mar 9, 2020

Last Update Posted Date

Mar 10, 2020Actual

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

OBJECTIVE:

To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft.

DESIGN:

Monocentric retrospective and prospective analysis of medical reports.

PATIENTS, PARTICIPANTS:

All consecutively treated patients affected by a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.

INTERVENTIONS:

Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated.

MAIN OUTCOME MEASURE(S):

The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with Cleft lip and palate		Children with Cleft lip and palate
Children with Cleft palate		Children with Cleft palate

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Audiometry	evaluation of the hearing threshold	1 day

Secondary Outcomes

Measure	Description	Time Frame
nasal ventilation	Nasal ventilation will be assessed with passive anterior rhinomanometry	1 day
Eustachian tube function	Eustachian tube function will be assessed with tubomanometry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria :

10 yo children with operated clefts followed in the universitary hospital of Montpellier
who went to the ENT check up

Exclusion criteria :

Thoses who skip the check up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

All consecutively treated patients affected by a cleft lip and palate or a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lylou Casteil Baume, ENT resident	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D002971	Cleft Lip
D002972	Cleft Palate

Ancestor Terms

ID	Term
D008047	Lip Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009056	Mouth Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided