VIS-Flanders: Vestibular Infants Screening-Flanders

Sponsor

University Hospital, Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT05061069

Collaborator

Universitair Ziekenhuis Brussel (Other), Universitaire Ziekenhuizen Leuven (Other), Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other), Queen Fabiola Children's University Hospital (Other), AZ Turnhout (Other), Gasthuis Zusters Antwerpen (Other), GZA Ziekenhuizen Campus Sint-Augustinus (Other), University Hospital, Antwerp (Other), Jessa Hospital (Other), Ziekenhuis Oost-Limburg (Other), Algemeen Stedelijk Ziekenhuis (Other), Algemeen Ziekenhuis Maria Middelares (Other), AZ Delta (Other), AZ Sint-Jan AV (Other), AZ Sint-Lucas Brugge (Other), Eargroup (Other), Sint-Lievenspoort Gent (Other), CAR Stappie (Other)

254

Enrollment

Locations

Arm

50.3

Actual Duration (Months)

13.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibular Disorder Hearing Impaired Children	Diagnostic Test: cervical vestibular evoked myogenic potentials (cVEMP)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

254 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Multicenter non-commercial interventional academic researchMulticenter non-commercial interventional academic research

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Aug 11, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital	Ghent	East-Flanders	Belgium	9000
2	Algemeen Stedelijk Ziekenhuis	Aalst		Belgium
3	Algemeen Ziekenhuis Maria Middelares	Aalst		Belgium
4	Eargroup	Antwerp		Belgium
5	Gasthuis Zusters Antwerpen	Antwerp		Belgium
6	GZA Ziekenhuizen Campus Sint-Augustinus	Antwerp		Belgium
7	University Hospital Antwerp	Antwerp		Belgium
8	AZ Sint-Jan	Brugge		Belgium
9	AZ Sint-Lucas Brugge	Brugge		Belgium
10	Cliniques universitaires Saint-Luc	Brussels		Belgium
11	Queen Fabiola Children's University Hospital	Brussels		Belgium
12	Universitair Ziekenhuis Brussel	Brussels		Belgium
13	Ziekenhuis Oost-Limburg	Genk		Belgium
14	Sint-Lievenspoort Gent	Gent		Belgium
15	Jessa Hospital	Hasselt		Belgium
16	Universitair Ziekenhuis Leuven	Leuven		Belgium
17	AZ Delta	Menen		Belgium
18	CAR Stappie	Oostende		Belgium
19	AZ Turnhout	Turnhout		Belgium