Implementation of a Standard Vestibular Screening Protocol for Hearing-impaired Infants in Flanders
Phase: NA
Conditions: Vestibular Disorder, Hearing Impaired Children
Sponsor: University Hospital, Ghent

Protocol VIS-Flanders 21.05.2024 
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Study protocol: VIS-Flanders 
 
 
Title 
Implementation of a standard vestibular screening protocol for hearing- 
impaired children in Flanders. 
Identifier 
NCT05061069 
Document Date 
21.05.2024 
Study type 
Multicenter non-commercial interventional academic research 
Sponsor 
University Hospital Ghent (UZ Gent) 
Principal investigator 
Prof. Dr. Ingeborg Dhooge 
Ingeborg.Dhooge@UGent.be 
Leading Ethical 
Committee 
Ethical Committee of UZ Gent 
Ethisch.Comite@UGent.be 
Summary/Scientific 
background 
Vestibular Infant Screening-Flanders (VIS-Flanders) is financially 
supported by the Research Foundation – Flanders (FWO). This project 
investigates the vestibular function in Flemish hearing- impaired 
children at the age of six months by using a screening tool. VIS-
Flanders is the result of a cooperation between the department of 
Rehabilitation Sciences at the Ghent University and the Ear, Nose and 
Throat department at the Ghent University Hospital. 
A vestibular (balance) dysfunction can compromise the development of 
a child on many levels. One of the most important consequences of a 
vestibular dysfunction is the higher risk for motor deficits. In this 
context, a highly vulnerable group comprises children with a hearing 
loss. Because of the close anatomical relationship between the 
auditory (hearing) and vestibular (balance) organs, it seems evident 
that an inner ear disease may affect not only the auditory, but also the 
vestibular function. Whereas vestibular and motor assessment in 
hearing-impaired children is standard of care in the Ghent University 
Hospital, this is currently not a standard component in the diagnostic 
follow-up of hearing-impaired children in other care centres in 
Flanders. Therefore, vestibular deficits in hearing-impaired children 
currently often go unnoticed, giving rise to associated disorders such 
as a delayed motor development, behavioral disorders, etc. 
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. 

Protocol VIS-Flanders 21.05.2024 
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Objectives 
The main objective of this TBM-project is to limit the impact of a vestibular 
dysfunction on the motor, cognitive and psychosocial development of 
hearing-impaired children. In order to achieve this goal, we aim to 
implement a standard vestibular screening protocol in Flanders for all 
children with a hearing loss, detected by a ‘refer’ on the neonatal hearing 
screening (Kind & Gezin) and confirmed by a diagnostic hearing 
evaluation in one of the reference centres in Flanders. The vestibular 
screening would be scheduled at the age of 6 months in order to expedite 
the early detection of vestibular deficits and subsequent referral for 
rehabilitation. 
Design & methodology  
Multicenter non-commercial interventional academic research. 
 
The aim of the TBM-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 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. 
Number of study patients 
and duration 
From June 2018 until June 2021 approximately 360 patients will be 
tested in all participating centers in Flander and Brussels (in the end, 
301 infants were screened, 47 were excluded, and 254 infants were 
included in the study.  
Type of patients 
Children with a confirmed hearing-loss about the age of 6 months old 
(between 0 and 1 year old) 
Statistical Analysis Plan 
Statistical analysis will be completed with SPSS software (IBM, 
version 27.0, Armonk, NY). 
On subject level, abnormal screening results indicate abnormal 
responses in at least 1 ear, and the degree of hearing loss will be 
categorized according to the worst ear in case of bilateral hearing 
loss. The two-tailed Fisher’s Exact test will be used to evaluate the 
association between screening results and possible predisposing 
factors. 
On ear level, data will be analyzed more in-depth by means of 
generalized estimating equations, which takes the clustered data 
structure (ie, 2 ears within 1 child) into account and provides a robust 
estimator of the covariance matrix. Odds ratios (OR) with 95% 
confidence intervals (95% CI) will be reported. The significance level 
(ie, two-tailed) will be set at P < .01 to correct for multiple testing.