None listed
Conditions
Brief summary
1. What is the research project about? Babies can be born with different degrees of hearing loss. Hearing aids are generally provided to them to help them hear well. Whilst we know that hearing aids help babies with moderate or greater degrees of hearing loss, we do not know whether hearing aids are helpful for babies with mild hearing loss, even though they are often offered to these babies. This is a pilot study that will help us plan for a bigger study in the future to increase knowledge about whether hearing aids help babies with mild hearing loss.Hearing aids can help babies with moderate or greater degrees of hearing loss to hear. However,, but we do not know whether they help babies with mild hearing loss even though they are commonly offered hearing aids. . This study is a first step to collect information that we hope will lead to a larger study to helps us answer this important question. 2. Who is running the project? The study is run by a team based at the Murdoch Children’s Research Institute (MCRI) in Melbourne and the National Acoustic Laboratories (NAL) in Victoria, New South Wales and Queensland. MCRI is the research institute affiliated with the Royal Children’s Hospital in Melbourne and is the largest child health research institute in Australia. NAL is the research arm of Australian Hearing, which is responsible for looking after the hearing health of all children with hearing loss in Australia. The study is funded by a philanthropic grant from the Garnett Passe and Rodney Williams Memorial Foundation.
Interventions
INTERVENTION
Intervention arms:
This is a two arm trial with a single intervention arm. Children in the intervention group will receive hearing devices. Timing of fitting, model of hearing devices and clinical care will be determined by the AH audiologist in each case.
Children in the control arm of the RCT receive usual follow up by their clinical audiologist and will not be fitted with hearing devices.
Intervention(s):
The intervention consists of hearing devices fitting and follow up of hea
INTERVENTION Intervention arms: This is a two arm trial with a single intervention arm. Children in the intervention group will receive hearing devices. Timing of fitting, model of hearing devices and clinical care will be determined by the AH audiologist in each case. Children in the control arm of the RCT receive usual follow up by their clinical audiologist and will not be fitted with hearing devices. Intervention(s): The intervention consists of hearing devices fitting and follow up of hearing devices compliance and parent support over 6 months. The process involves: 1. Assessment and clinical counselling by a AH audiologist regarding bilateral hearing devices fitting, to take place at the AH centre convenient to the family; 2. Fitting adjustment, data-logging and follow up appointments at AH centre as clinically required; 3. Monthly follow up by the Mild Matters study team to monitor compliance. This follow-up will be a five question survey sent in a web-link to the parent’s mobile phone / email address (or mailed paper questionnaire / phone call). In the rare circumstance where parents request for hearing device fitting in only one ear, the child will still be eligible for the intervention and will not be excluded from the study. Participants who withdraw early will be given the option to complete the final survey if they wish to, including all parent measures. The child will not be offered a direct assessment unless they have completed 4 out of the 6 months of the intervention.
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
Infants must meet all of the following criteria to be enrolled in the study: 1. Born in Victoria, New South Wales, or Queensland and eligible for services of Hearing Australia (Australian resident/citizenship status) 2. Less than 2 years old 3. Have parents/carers who speak English adequately to give consent 4. Have, within the last 3 months, been confirmed to have bilateral mild hearing loss (3 frequency average <=40dB eHL between 250 to 4000 Hz) by objective testing or behavioural testing. 5. Have pure sensorineural hearing loss
Exclusion criteria
Children with any of the following criteria will be excluded from the study: 1. Families who have already made a decision of fitting/not fitting hearing devices for their children with mild bilateral hearing loss 2. Complex medical problems / major disabilities e.g. recurrent seizures, major cardiac problems requiring multiple operations 3. Any conductive hearing loss 4. Medical contraindication to hearing devices fitting 5. Families who definitively plan to move, during the following 6 months, to a location where follow-up assessment is not possible or practical
Outcome results
None listed