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Clinical Trials/NCT04367961
NCT04367961
Completed
N/A

Auditory Profile and Language Development in Children Operated for Cleft Palate

Assistance Publique - Hôpitaux de Paris1 site in 1 country50 target enrollmentMarch 11, 2020
ConditionsDeafness

Overview

Phase
N/A
Intervention
Not specified
Conditions
Deafness
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
50
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
5 years ago

Overview

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. "

Registry
clinicaltrials.gov
Start Date
March 11, 2020
End Date
July 29, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 1 day

The hearing profile is assessed though an audiogram once or twice a year during the annual follow-up with the referring surgeon. The hearing test will be adapted depending the age of the child. Language development is assessed by the intelligibility scale, a validated questionnaire. The parent is answering the questionnaire.

Study Sites (1)

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