Clinical Trials Directory

Trials / Completed

CompletedNCT04367961

Auditory Profile and Language Development in Children Operated for Cleft Palate

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
5 Years – 11 Years
Healthy volunteers

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. "

Conditions

Timeline

Start date
2020-03-11
Primary completion
2020-07-29
Completion
2020-07-29
First posted
2020-04-29
Last updated
2020-10-06

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04367961. Inclusion in this directory is not an endorsement.