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Clinical Trials/NCT03708406
NCT03708406
Completed
Not Applicable

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

University Hospital, Montpellier1 site in 1 country60 target enrollmentOctober 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cleft Lip and Palate
Sponsor
University Hospital, Montpellier
Enrollment
60
Locations
1
Primary Endpoint
Audiometry
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2018
End Date
December 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Audiometry

Time Frame: 1 day

evaluation of the hearing threshold

Secondary Outcomes

  • nasal ventilation(1 day)
  • Eustachian tube function(1 day)
  • Facial 3D scan(1 day)

Study Sites (1)

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