Trial Outcomes & Findings for Vestibular Infants Screening-Flanders (NCT NCT05061069)
NCT ID: NCT05061069
Last Updated: 2025-02-12
Results Overview
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.
COMPLETED
NA
301 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.
2025-02-12
Participant Flow
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.
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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301
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Overall Study
COMPLETED
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301
|
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Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Infants With Permanent Hearing Loss
n=301 Participants
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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|---|---|
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Age, Categorical
<=18 years
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301 Participants
n=301 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=301 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=301 Participants
|
|
Age, Continuous
|
7.4 months
STANDARD_DEVIATION 2.4 • n=301 Participants
|
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Sex: Female, Male
Female
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153 Participants
n=301 Participants
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Sex: Female, Male
Male
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148 Participants
n=301 Participants
|
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Region of Enrollment
Belgium
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301 participants
n=301 Participants
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Infant with permanent hearing loss
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301 Participants
n=301 Participants
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PRIMARY outcome
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.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
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.
Outcome measures
| Measure |
Infants With Permanent Hearing Loss
n=254 Participants
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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Number of Hearing-impaired Infants in Flanders With Abnormal Vestibular Screening Results.
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35 Participants
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Adverse Events
Infants With Permanent Hearing Loss
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place