Hearing Impaired Children, Vestibular Disorder
Conditions
Keywords
vestibular, balance, hearing loss, infants
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.
Interventions
DIAGNOSTIC_TESTcervical 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.
Sponsors
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
Sint-Lievenspoort Gent
Center for Developmental and Hearing Disorders
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Multicenter non-commercial interventional academic research
Eligibility
Sex/Gender
ALL
Age
4 Months to 24 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results. | 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. | 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. |
Countries
Belgium
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 301 |
| Total | 301 |
Baseline characteristics
| Characteristic | Infants With Permanent Hearing Loss | — |
|---|---|---|
| Age, Categorical <=18 years | 301 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Age, Continuous | 7.4 months STANDARD_DEVIATION 2.4 | — |
| Infant with permanent hearing loss | 301 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 301 participants | — |
| Sex: Female, Male Female | 153 Participants | — |
| Sex: Female, Male Male | 148 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
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.
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infants With Permanent Hearing Loss | Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results. | 35 Participants |