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Vestibular Infants Screening-Flanders (VIS-Flanders)

Primary Purpose

Vestibular Disorder, Hearing Impaired Children

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
cervical vestibular evoked myogenic potentials (cVEMP)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vestibular Disorder focused on measuring vestibular, balance, hearing loss, infants

Eligibility Criteria

4 Months - 24 Months (Child)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infants with permanent hearing loss

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2021
Last Updated
August 16, 2022
Sponsor
University Hospital, Ghent
Collaborators
Universitair Ziekenhuis Brussel, Universitaire Ziekenhuizen KU Leuven, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Queen Fabiola Children's University Hospital, AZ Turnhout, Gasthuis Zusters Antwerpen, GZA Ziekenhuizen Campus Sint-Augustinus, University Hospital, Antwerp, Jessa Hospital, Ziekenhuis Oost-Limburg, Algemeen Stedelijk Ziekenhuis, Algemeen Ziekenhuis Maria Middelares, AZ Delta, AZ Sint-Jan AV, AZ Sint-Lucas Brugge, Eargroup, Sint-Lievenspoort Gent, CAR Stappie
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1. Study Identification

Unique Protocol Identification Number
NCT05061069
Brief Title
Vestibular Infants Screening-Flanders
Acronym
VIS-Flanders
Official Title
Implementation of a Standard Vestibular Screening Protocol for Hearing-impaired Infants in Flanders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 11, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder, Hearing Impaired Children
Keywords
vestibular, balance, hearing loss, infants

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter non-commercial interventional academic research
Masking
None (Open Label)
Allocation
N/A
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infants with permanent hearing loss
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
cervical vestibular evoked myogenic potentials (cVEMP)
Intervention Description
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 Outcome Measure Information:
Title
Number of hearing-impaired infants in Flanders with abnormal vestibular screening results.
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leen Maes, Prof. Dr.
Organizational Affiliation
University Ghent
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ingeborg Dhooge, Prof. Dr.
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Algemeen Stedelijk Ziekenhuis
City
Aalst
Country
Belgium
Facility Name
Algemeen Ziekenhuis Maria Middelares
City
Aalst
Country
Belgium
Facility Name
Eargroup
City
Antwerp
Country
Belgium
Facility Name
Gasthuis Zusters Antwerpen
City
Antwerp
Country
Belgium
Facility Name
GZA Ziekenhuizen Campus Sint-Augustinus
City
Antwerp
Country
Belgium
Facility Name
University Hospital Antwerp
City
Antwerp
Country
Belgium
Facility Name
AZ Sint-Jan
City
Brugge
Country
Belgium
Facility Name
AZ Sint-Lucas Brugge
City
Brugge
Country
Belgium
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
Country
Belgium
Facility Name
Queen Fabiola Children's University Hospital
City
Brussels
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
Sint-Lievenspoort Gent
City
Gent
Country
Belgium
Facility Name
Jessa Hospital
City
Hasselt
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
Country
Belgium
Facility Name
AZ Delta
City
Menen
Country
Belgium
Facility Name
CAR Stappie
City
Oostende
Country
Belgium
Facility Name
AZ Turnhout
City
Turnhout
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared as data related to health of patients is included.
Citations:
PubMed Identifier
30849604
Citation
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.
Results Reference
background
PubMed Identifier
33273502
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, 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.
Results Reference
result
PubMed Identifier
35698886
Citation
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.
Results Reference
derived
Links:
URL
http://VIS-Flanders.be/en/
Description
VIS-Flanders website for patients and health care workers

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Vestibular Infants Screening-Flanders

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