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Clinical Trial Summary

There is high variability in outcomes in children with hearing impairment. Existing literature focus mainly on subpopulations (children with hearing aids, children with CI) and is usually not epidemiological. Often children with additional needs (intellectual disability, visual impairment, autism spectrum disorder, complex syndromes) are excluded from the studies. This subgroup of children makes up around 1/3 of the population of children with hearing impairment. What factors contribute to the unexplained variance in language development in children with hearing loss? (including children with additional needs, multilingual) There is a lack of European epidemiological studies that evaluate the effects of Newborn Hearing Screening and early intervention.


Clinical Trial Description

Aims: - to collect population based data on children born in Upper Austria with a significant hearing impairment and to describe this population in detail regarding audiological, etiological (including geno- and phenotypical correlations), neurodevelopmentally, psychological, psychiatrically and linguistically with a special interest is in children with additional needs - collecting child development outcomes (language, communication, psychosocial) and family outcomes (quality of life, stress) - to investigate possible effects of the Newborn Hearing Screening, early intervention and specific parent behaviors targeted in early intervention - collecting developmental trajectories of the total sample and subgroups of the sample (particularly audiological, etiological and cognitive). This data should help identify red flags - investigating predictors of developmental trajectories regarding the child and the intervention (e.g. time and Hypothesis: - It is expected that .2% of the total population of preschool children have a sensorineural hearing loss (bilateral and unilateral) - a significantly higher prevalence of intellectual disabilities (up to 20%), visual impairment, autism spectrum disorder and motor impairment - it is expected that for at least 50% of the children, there is a genetic explanation for the hearing impairment and 30% out of them are expected to be syndromal - it is expected that there is a higher proportion of children with psycho-social problems (especially peer problems and behavioral-/emotional problems) - Due to a change in the environmental conditions over the past two decades, better child outcomes, compared to previous ones are expected. Nevertheless around 30-50% of the children are expected to not be reaching their nonverbal cognitive potential. - expected intervention effects, particularly for provision with and use of hearing technology family-child interaction self-efficacy and wellbeing of the family regulated media use ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04317456
Study type Observational [Patient Registry]
Source Johannes Kepler University of Linz
Contact Daniel Holzinger, PhD
Phone 00437327897
Email daniel.holzinger@bblinz.at
Status Recruiting
Phase
Start date September 1, 2019
Completion date August 2025

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