Otologic and Rhinologic Outcomes in Children With Clef Palate (Clef Palate)

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

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.

Study Overview

• Status: Completed
• Conditions: Cleft Lip and Palate

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Children with Cleft lip and palate
Children with Cleft palate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	1 day
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Lylou Casteil Baume, ENT resident, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: cleft palate; Eustachian dysfunction; Obstructive ventilation
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: RECHMPL18_0374

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No