Vestibular Infants Screening-Flanders

Not Applicable

Completed

• Conditions: Vestibular Disorder; Hearing Impaired Children

• Registration Number: NCT05061069
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Hearing-impaired children are at risk for a vestibular impairment, as the auditory and vestibular end organs are closely related. Although this can compromise a child's development on many levels, vestibular testing is not routinely performed in this vulnerable group. This project aims to give each congenitally hearing-impaired child in Flanders (Belgium) access to a basic vestibular screening at a young age and set an example for other regions worldwide.

Detailed Description

The implementation of a vestibular screening in hearing-impaired babies of six months old will timely discover vestibular problems to limit the impact on the (motor) development. The cervical vestibular evoked myogenic potential (cVEMP) technique will be used as a vestibular screening tool. Flanders is the first region worldwide that will implement a vestibular screening. All official Flemish reference centres of Kind en Gezin (Child and Family) will participate in this project.

Study purpose:

The final utilisation goal of this project is to limit the impact of a vestibular dysfunction on the (motor) development of children. Since hearing-impaired children have a higher risk for deficits of the vestibular (balance) organ, the researchers will focus on this vulnerable group.

This will be accomplished by:

* The implementation of a standard vestibular screening protocol in Flanders in hearing-impaired children at the age of 6 months, enabling early diagnosis of vestibular deficits and adequate referral for extensive vestibular testing, motor assessment and rehabilitation.

* Increasing the awareness for vestibular dysfunctions and its associated symptoms in hearing-impaired children among parents, teachers, paramedics, specialists and other social workers who are in close contact with hearing-impaired children. This should go hand in hand with more effective patient care, because adequate therapy will start sooner.

Methodology:

The aim of the project is to add a vestibular screening to the existing auditory screening programme (MAICO test). The following steps will be performed to guarantee an accurate vestibular follow-up in Flemish hearing-impaired children:

* In case of a 'refer' on the second MAICO test, Kind en Gezin (Child and Family) will refer the child to the reference centres of Kind en Gezin in Flanders.

* These reference centres will perform a diagnostic hearing test (brainstem evoked response audiometry: BERA) to confirm the permanent hearing loss (standard of care).

* Each child with a confirmed hearing loss (BERA 'refer') will be subjected to a vestibular screening at the age of six months (on average 120/year), combined with tympanometry, in that specific reference centre at the age of six months. The cervical vestibular evoked myogenic potential (cVEMP) technique will be used.

* In case of a refer on the vestibular screening (cVEMP 'refer'), the reference centres will refer the child for motor assessment and, if necessary, for rehabilitation.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2021-07-01
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-29
• Study Completion: 2022-08-11
• Results First Submitted: 2022-11-15
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Results First Posted: 2025-02-12
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• Flemish children with permanent congenital or delayed-onset hearing loss, which occurred before the age of 9 months, are included.

Exclusion Criteria

• Children with temporary hearing loss (e.g. due to otitis media) are excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results.	Each infants will be subjected to the screening at the age of six months. In case of inconclusive results during the first screening, the screening will be repeated within three months after the first screening moment.	The primary outcome measure is the number of hearing-impaired infants in Flanders with abnormal vestibular screening results according to the degree, laterality, and onset of hearing loss. Abnormality of the vestibular screening results is based on the rectified interpeak amplitude values of the cVEMP (cervical vestibular evoked myogenic potentials) responses.

Trial Locations

Locations (19)

Ghent University Hospital; 🇧🇪 Ghent, East-Flanders, Belgium

Algemeen Stedelijk Ziekenhuis; 🇧🇪 Aalst, Belgium

Algemeen Ziekenhuis Maria Middelares; 🇧🇪 Aalst, Belgium

Eargroup; 🇧🇪 Antwerp, Belgium

Gasthuis Zusters Antwerpen; 🇧🇪 Antwerp, Belgium

GZA Ziekenhuizen Campus Sint-Augustinus; 🇧🇪 Antwerp, Belgium

University Hospital Antwerp; 🇧🇪 Antwerp, Belgium

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

AZ Sint-Lucas Brugge; 🇧🇪 Brugge, Belgium

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

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