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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03708406
Recruitment Status : Active, not recruiting
First Posted : October 17, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease
Cleft Lip and Palate

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Otologic and Rhinologic Outcomes in Children With Cleft Palate at Age 10 Years
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Audiometry [ Time Frame: 1 day ]
    evaluation of the hearing threshold


Secondary Outcome Measures :
  1. nasal ventilation [ Time Frame: 1 day ]
    Nasal ventilation will be assessed with passive anterior rhinomanometry

  2. Eustachian tube function [ Time Frame: 1 day ]
    Eustachian tube function will be assessed with tubomanometry

  3. Facial 3D scan [ Time Frame: 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)


Biospecimen Retention:   None Retained
Middle ear effusion fluids


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708406


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Lylou Casteil Baume, ENT resident University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03708406     History of Changes
Other Study ID Numbers: RECHMPL18_0374
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
cleft palate
Eustachian dysfunction
Obstructive ventilation
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities