Clinical trial NCT05061069: Vestibular Infants Screening-Flanders
Official title: Implementation of a Standard Vestibular Screening Protocol for Hearing-impaired Infants in Flanders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Hearing Impaired Children
Keywords: vestibular
balance
hearing loss
infants
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
name: Universitaire Ziekenhuizen KU Leuven
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Queen Fabiola Children's University Hospital
name: AZ Turnhout
name: Gasthuis Zusters Antwerpen
name: GZA Ziekenhuizen Campus Sint-Augustinus
name: University Hospital, Antwerp
name: Jessa Hospital
name: Ziekenhuis Oost-Limburg
name: Algemeen Stedelijk Ziekenhuis
name: Algemeen Ziekenhuis Maria Middelares
name: AZ Delta
name: AZ Sint-Jan AV
name: AZ Sint-Lucas Brugge
name: Sint-Lievenspoort Gent
name: Center for Developmental and Hearing Disorders
First posted: 2021-09-29
Enrollment: 301
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter non-commercial interventional academic research
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East-Flanders
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
city: Aalst
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
city: Antwerp
country: Belgium
facility: Eargroup
city: Antwerp
country: Belgium
facility: Gasthuis Zusters Antwerpen
city: Antwerp
country: Belgium
facility: GZA Ziekenhuizen Campus Sint-Augustinus
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Brugge
country: Belgium
facility: AZ Sint-Lucas Brugge
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Brussels
country: Belgium
facility: Queen Fabiola Children's University Hospital
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: Sint-Lievenspoort Gent
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Menen
country: Belgium
facility: AZ Delta
city: Oostende
country: Belgium
facility: CAR Stappie
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
affiliation: University Ghent
name: Leen Maes, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University Hospital, Ghent
name: Ingeborg Dhooge, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.