Vestibular Infants Screening-Flanders

Vestibular Disorder Clinical Trial

— VIS-Flanders  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05061069
• Other study ID #: 2018/0435
• Secondary ID: T000917N
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: August 11, 2022

Study information

• Verified date: September 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: August 11, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Impaired Children
• Hearing Loss
• Vestibular Diseases
• Vestibular Disorder

Intervention

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.

Locations

Country	Name	City	State
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	Queen Fabiola Children's University Hospital	Brussels
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Sint-Lievenspoort Gent	Gent
Belgium	Ghent University Hospital	Ghent	East-Flanders
Belgium	Jessa Hospital	Hasselt
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	AZ Delta	Menen
Belgium	CAR Stappie	Oostende
Belgium	AZ Turnhout	Turnhout

Sponsors (19)

Lead Sponsor

Collaborator

University Hospital, Ghent

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

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   VIS-Flanders website for patients and health care workers