Auditory Profile and Language Development in Children Operated for Cleft Palate

NCT ID: NCT04367961

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-11

Study Completion Date

2020-07-29

Brief Summary

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Observational study about children with cleft palate from surgery to pre-adolescence :Description of language development and hearing profile.

Detailed Description

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"Children with cleft palates are prone to complications that can impact on their overall development. Several factors such as serous otitis media or abnormal musculature of the velum can have consequences on hearing and language. In this context, it seems important to describe the evolution of this disease after surgery to better anticipate complications and improve their subsequent management. The aim of this study is to describe the hearing profile and language development of children with cleft palate from surgery to pre-adolescence. The hearing profile is assessed though an audiogram once or twice a year during the annual follow-up with the referring surgeon. Language development is assessed by the intelligibility scale, a validated questionnaire. This study will allow identification of : - predictive criteria for poor hearing and poor language development; - risk groups: type of cleft, medical history, genetic background, etc; - Level of speech disorder other than intelligibility: rhinolalia, eagerness for communication; - Other factors in the history of the disease: âge at surgery ; - history of chronic otitis media, ventilation tube placements; - nasalization and language disorder; - speech-language pathology; - History of hearing impairment; - age of first words; - Other ENT clinical history; - History of malformations; - Socio-economic level of the household; - Mother's language / number of languages spoken at home. This is a retrospective and prospective cohort study. Children aged 5 to 11 with a cleft palate operated on for a veloplasty at Robert Debré Hospital between 2008 and 2014 were included in the study between 2008 and 2014.

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Conditions

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Deafness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Children aged 5 to 11 years old operated on for a veloplasty at the Robert Debré Hospital
* operated between 2008 and 2014
* having a cleft veil with or without a cleft lip and palate

Exclusion Criteria

* Children operated on for primary veloplasty outside the Robert Debré Hospital, and coming for secondary veloplasty.

Child operated on for a veloplasty for a cause other than the velar cleft.
Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Robert Debré Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2019-A01660-57

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190493

Identifier Type: -

Identifier Source: org_study_id

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