NCT03708406|Completed
Otologic and Rhinologic Outcomes in Children With Clef Palate
Clef Palate
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Clef Palate
Sponsor study identifier
observational
60
1 country
1
Study Start
October 12, 2018
Actual (reported)Primary Completion
December 1, 2019
Actual (reported)Study Completion
December 30, 2019
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 2018
Actual (reported)October 12, 2018
Actual (reported)October 17, 2018
Actual (reported)December 1, 2019
Actual (reported)December 30, 2019
Actual (reported)Audiometry
evaluation of the hearing threshold
1 day
nasal ventilation
1 day
Eustachian tube function
1 day
Facial 3D scan
1 day
Children with Cleft lip and palate
Children with Cleft palate
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.
Uhmontpellier
Montpellier, 34295, France
Middle ear effusion fluids
Lylou Casteil Baume, ENT resident
University Hospital, Montpellier
60 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2018
First Posted
October 17, 2018
Study Start
October 12, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 1, 2019
Actual (reported)Study Completion
December 30, 2019
Actual (reported)Last Updated
March 10, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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