Auditory Profile and Language Development in Children Operated for Cleft Palate

Deafness Clinical Trial

— VELAUDI  

Official title:

Auditory Profile and Language Development in Children Operated for Cleft Palate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367961
• Other study ID #: APHP190493
• Secondary ID: 2019-A01660-57
• Status: Completed
• Start date: March 11, 2020
• Est. completion date: July 29, 2020

Study information

• Verified date: April 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2020
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate
• Deafness

Locations

Country	Name	City	State
France	Robert Debré Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 day