Study Results
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View full resultsBasic Information
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COMPLETED
NA
301 participants
INTERVENTIONAL
2018-06-01
2022-08-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Months
24 Months
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Universitaire Ziekenhuizen KU 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
Sint-Lievenspoort Gent
UNKNOWN
Center for Developmental and Hearing Disorders
UNKNOWN
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Leen Maes, Prof. Dr.
Role: STUDY_DIRECTOR
University Ghent
Ingeborg Dhooge, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, East-Flanders, 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
Bruges, , Belgium
AZ Sint-Lucas Brugge
Bruges, , 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
Ghent, , Belgium
Jessa Hospital
Hasselt, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
AZ Delta
Menen, , Belgium
CAR Stappie
Ostend, , Belgium
AZ Turnhout
Turnhout, , Belgium
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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VIS-Flanders website for patients and health care workers
Other Identifiers
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T000917N
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2018/0435 (BC-2604)
Identifier Type: -
Identifier Source: org_study_id
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