Otologic and Rhinologic Outcomes in Children With Clef Palate

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03708406

Acronym

Clef Palate

Enrollment

Registered

2018-10-17

Start date

2018-10-12

Completion date

2019-12-30

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Keywords

cleft palate, Eustachian dysfunction, Obstructive ventilation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Years to 11 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
nasal ventilation	1 day	Nasal ventilation will be assessed with passive anterior rhinomanometry
Eustachian tube function	1 day	Eustachian tube function will be assessed with tubomanometry
Facial 3D scan	1 day	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)

Countries

France

Outcome results