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| ID | Type | Description | Link |
|---|---|---|---|
| T000917N | Other Grant/Funding Number | Research Foundation-Flanders |
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| Name | Class |
|---|---|
| Universitair Ziekenhuis Brussel | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| Cliniques universitaires Saint-Luc- Université Catholique de Louvain | OTHER |
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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants with permanent hearing loss | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cervical vestibular evoked myogenic potentials (cVEMP) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leen Maes, Prof. Dr. | University Ghent | Study Director |
| Ingeborg Dhooge, Prof. Dr. | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | East-Flanders | 9000 | Belgium | ||
| Algemeen Stedelijk Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30849604 | Background | 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. | |
| 33273502 |
| Label | URL |
|---|---|
| VIS-Flanders website for patients and health care workers | View source |
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Individual participant data will not be shared as data related to health of patients is included.
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The vestibular screening was offered to all Flemish infants with permanent hearing loss around the age of 6 months in 1 of the 25 reference centers involved in the UNHSP.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
301 infants were screened, 47 were excluded for analysis, so the cVEMP data of 254 infants was eventually included and analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Overall, 301 infants were screened, of which 47 infants were excluded for data analysis. Excluded infants: Bilateral normal hearing during audiological follow-up: n = 9 Parents declined retest in case of initial inconclusive results: n = 6 Delayed-onset hearing loss after ten months of age: n = 1 Permanent conductive hearing loss due to external auditory canal atresia: n = 22 Parents gave consent to perform the cVEMP, but did not give consent to analyze and include the data: n = 9 | Posted | Count of Participants | Participants | 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. |
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All-cause mortality, serious, and other (not including serious) adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Leen Maes | Ghent University | 093324066 | +32 | leen.maes@ugent.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2024 | Jan 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006311 | Hearing Disorders |
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| ID | Term |
|---|---|
| D058585 | Vestibular Evoked Myogenic Potentials |
| ID | Term |
|---|---|
| D019054 | Evoked Potentials, Motor |
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
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| 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 |
Multicenter non-commercial interventional academic research
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| 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 |
| 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. |
| 32590628 | Result | 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. |
| 35698886 | Derived | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Infant with permanent hearing loss | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | 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. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010829 | Physiological Phenomena |