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Completed

NCT Number: NCT05061069

Vestibular Infants Screening-Flanders

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.

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Key information

Age range

4 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital, Ghent, East-Flanders, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cervical vestibular evoked myogenic potentials (cVEMP)

Diagnostic Test

cVEMPs are ipsilateral, short latency, inhibitory myogenic potentials that assess otolith (mainly saccular) function and the integrity of the inferior branch of the vestibular nerve.

Primary outcomes

  1. Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • AZ Delta
  • AZ Sint-Jan AV
  • AZ Sint-Lucas Brugge
  • AZ Turnhout
  • Algemeen Stedelijk Ziekenhuis
  • Algemeen Ziekenhuis Maria Middelares
  • Center for Developmental and Hearing Disorders
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • GZA Ziekenhuizen Campus Sint-Augustinus
  • Gasthuis Zusters Antwerpen
  • Jessa Hospital
  • Queen Fabiola Children's University Hospital
  • Sint-Lievenspoort Gent
  • Universitair Ziekenhuis Brussel
  • Universitaire Ziekenhuizen KU Leuven
  • University Hospital, Antwerp
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

Implementation of a Standard Vestibular Screening Protocol for Hearing-impaired Infants in Flanders

Acronym: VIS-Flanders

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Sep 29, 2021
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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