Clinical trial NCT04367961: Auditory Profile and Language Development in Children Operated for Cleft Palate
Official title: Auditory Profile and Language Development in Children Operated for Cleft Palate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deafness
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with a cleft vein operated on for a veloplasty at Robert Debré Hospital

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

Detailed description: "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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Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré Hospital
Study officials:
References: