Vestibular Infants Screening-Flanders (VIS-Flanders)

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

Study Overview

• Status: Completed
• Conditions: Vestibular Disorder; Hearing Impaired Children
• Intervention / Treatment: Diagnostic test: cervical vestibular evoked myogenic potentials (cVEMP)

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 Type: Interventional
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Algemeen Stedelijk Ziekenhuis
  • Aalst, Belgium
    • Algemeen Ziekenhuis Maria Middelares
  • Antwerp, Belgium
    • University Hospital Antwerp
  • Antwerp, Belgium
    • Eargroup
  • Antwerp, Belgium
    • Gasthuis Zusters Antwerpen
  • Antwerp, Belgium
    • GZA Ziekenhuizen campus Sint-Augustinus
  • Brugge, Belgium
    • AZ Sint-Jan
  • Brugge, Belgium
    • AZ Sint-Lucas Brugge
  • Brussels, Belgium
    • Cliniques Universitaires Saint-Luc
  • Brussels, Belgium
    • Universitair Ziekenhuis Brussel
  • Brussels, Belgium
    • Queen Fabiola Children's University Hospital
  • Genk, Belgium
    • Ziekenhuis Oost-Limburg
  • Gent, Belgium
    • Sint-Lievenspoort Gent
  • Hasselt, Belgium
    • Jessa Hospital
  • Leuven, Belgium
    • Universitair Ziekenhuis Leuven
  • Menen, Belgium
    • AZ Delta
  • Oostende, Belgium
    • CAR Stappie
  • Turnhout, Belgium
    • AZ Turnhout
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infants with permanent hearing loss; Each infant with permanent hearing loss in Flanders will be offered a vestibular screening by means of the cVEMP (cervical vestibular evoked myogenic potentials) test to screen for vestibular deficits.	Diagnostic test: cervical vestibular evoked myogenic potentials (cVEMP); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results.	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.	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.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Jessa Hospital; Queen Fabiola Children's University Hospital; Universitair Ziekenhuis Brussel; University Hospital, Antwerp; AZ Sint-Jan AV; AZ Delta; AZ Turnhout; Cliniques universitaires Saint-Luc- Université Catholique de Louvain; Ziekenhuis Oost-Limburg; Algemeen Ziekenhuis Maria Middelares; GZA Ziekenhuizen Campus Sint-Augustinus; AZ Sint-Lucas Brugge; Gasthuis Zusters Antwerpen; Algemeen Stedelijk Ziekenhuis; Sint-Lievenspoort Gent; Center for Developmental and Hearing Disorders
• Investigators: Study Director: Leen Maes, Prof. Dr., University Ghent; Principal Investigator: Ingeborg Dhooge, Prof. Dr., University Hospital, Ghent

Publications and helpful links

General Publications

• Martens S, Dhooge I, Dhondt C, Leyssens L, Sucaet M, Vanaudenaerde S, Rombaut L, Maes L. Vestibular Infant Screening - Flanders: The implementation of a standard vestibular screening protocol for hearing-impaired children in Flanders. Int J Pediatr Otorhinolaryngol. 2019 May;120:196-201. doi: 10.1016/j.ijporl.2019.02.033. Epub 2019 Feb 25.
• Martens S, Dhooge I, Dhondt C, Vanaudenaerde S, Sucaet M, Rombaut L, Boudewyns A, Desloovere C, Janssens de Varebeke S, Vinck AS, Vanspauwen R, Verschueren D, Foulon I, Staelens C, Van den Broeck K, De Valck C, Deggouj N, Lemkens N, Haverbeke L, De Bock M, Oz O, Declau F, Devroede B, Verhoye C, Maes L. Vestibular Infant Screening (VIS)-Flanders: results after 1.5 years of vestibular screening in hearing-impaired children. Sci Rep. 2020 Dec 3;10(1):21011. doi: 10.1038/s41598-020-78049-z.
• Martens S, Dhooge I, Dhondt C, Vanaudenaerde S, Sucaet M, Van Hoecke H, De Leenheer E, Rombaut L, Boudewyns A, Desloovere C, Vinck AS, de Varebeke SJ, Verschueren D, Verstreken M, Foulon I, Staelens C, De Valck C, Calcoen R, Lemkens N, Oz O, De Bock M, Haverbeke L, Verhoye C, Declau F, Devroede B, Forton G, Deggouj N, Maes L. Three Years of Vestibular Infant Screening in Infants With Sensorineural Hearing Loss. Pediatrics. 2022 Jul 1;150(1):e2021055340. doi: 10.1542/peds.2021-055340.
• Dhondt C, Maes L, Rombaut L, Martens S, Vanaudenaerde S, Van Hoecke H, De Leenheer E, Dhooge I. Vestibular Function in Children With a Congenital Cytomegalovirus Infection: 3 Years of Follow-Up. Ear Hear. 2021 Jan/Feb;42(1):76-86. doi: 10.1097/AUD.0000000000000904.

Helpful Links

• VIS-Flanders website for patients and health care workers

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: vestibular; infants; balance; hearing loss
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Labyrinth Diseases; Vestibular Diseases; Hearing Loss; Deafness
• Other Study ID Numbers: 2018/0435 (BC-2604); T000917N (Other Grant/Funding Number: Research Foundation-Flanders)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared as data related to health of patients is included.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No