Otologic and Rhinologic Outcomes in Children With Clef Palate

Cleft Lip and Palate Clinical Trial

— Clef Palate  

Official title:

Otologic and Rhinologic Outcomes in Children With Cleft Palate at Age 10 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708406
• Other study ID #: RECHMPL18_0374
• Status: Completed
• Start date: October 12, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Audiometry	evaluation of the hearing threshold	1 day
Secondary	nasal ventilation	Nasal ventilation will be assessed with passive anterior rhinomanometry	1 day
Secondary	Eustachian tube function	Eustachian tube function will be assessed with tubomanometry	1 day
Secondary	Facial 3D scan	Facial 3D scan will be used to measure 2 criteria : Total volum of the mastoid; Total volum of the mastoid's cells (pneumatization); Facial 3D scan will be used to measure 2 criteria : Total volum of the mastoid; Total volum of the mastoid's cells (pneumatization); Facial 3D scan will be used to measure 2 criteria : Total volum of the mastoid; Total volum of the mastoid's cells (pneumatization)	1 day