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Trial registered on ANZCTR


Registration number
ACTRN12618001608257
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
27/09/2018
Date last updated
11/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mild Matters – Randomised Controlled Trial of Amplification for Infants with Bilateral Mild Hearing Loss
Scientific title
Mild Matters – Randomised Controlled Trial in Infants with Bilateral Mild Hearing Loss to
determine whether early fitting of hearing devices is effective in improving language at 6 months after fitting, compared with not fitting hearing devices.
Secondary ID [1] 295868 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild bilateral sensorineural hearing impairment 309334 0
Condition category
Condition code
Ear 308199 308199 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312202 0
Rehabilitation
Intervention code [2] 312373 0
Treatment: Devices
Comparator / control treatment
Children in the control arm of the RCT receive usual follow up by their clinical audiologist and will not be fitted with hearing devices. There are no guidelines for the management of children with bilateral mild hearing loss. Management is determine by individual clinicians and parents, and differs between clinicians and states.

Control group
Active

Outcomes
Primary outcome [1] 307163 0
The primary outcome measure at 6 months post-fitting or post-enrolment is a validated language measure – the Preschool Language Scale -5 (PLS-5; Zimmerman et al, 2012). This measure will be directly administered to the child by a study RA at a location convenient to the family.
Timepoint [1] 307163 0
6 months post-randomisation.
Secondary outcome [1] 350945 0
Child Outcome 1) Social skills – measured by the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist, based on parent report, (Wetherby A, Prizant B. Communication and Symbolic Behavior Scales Developmental Profile Infant/Toddler Checklist. 2001.).

Timepoint [1] 350945 0
6 months post-randomisation.
Secondary outcome [2] 351638 0
Child Outcome 2) Functional performance and listening effort in everyday environments – measured by using the Parents’ Evaluation of Aural/oral functional performance of Children (PEACH-plus), (Ching T, Hill M, Marnane V. Parents’ Evaluation of Aural/Oral Performance of Children and Ease of Listening Form: PEACH+. 2007.).
Timepoint [2] 351638 0
6 months post-randomisation.
Secondary outcome [3] 351639 0
Parent outcome 1) Psychological well-being – measured by the Parenting Morale Index- (PMI) (Trute B, Hiebert-Murphy D. Predicting family adjustment and parenting stress in childhood: Disability services using brief assessment tools. Journal of Intellectual and Developmental Disability. 2005;30(4):217-25.).
Timepoint [3] 351639 0
6 months post-randomisation.
Secondary outcome [4] 351640 0
Parent Outcome 2) Parent-child relationship – measured by the Family Adjustment to Childhood Developmental Disability (19).
Timepoint [4] 351640 0
6 months post-randomisation.
Secondary outcome [5] 351641 0
Parent Outcome 3) Quality of life – measured by the Assessment of Quality of Life (AQoL-4D), (Trute B, Hiebert-Murphy D. Family adjustment to childhood developmental disability: A measure of parent appraisal of family impacts. . Pediatric Psychology. 2002;27(3):271-80.).

Timepoint [5] 351641 0
6 months post-randomisation.
Secondary outcome [6] 351642 0
Acceptability and feasibility of RCT 1) Number of children enrolled as a proportion of eligible children.

Timepoint [6] 351642 0
6 months post-randomisation.
Secondary outcome [7] 351643 0
Acceptability and feasibility of RCT 2) Number of children who drop out as a proportion of enrolled children.
Timepoint [7] 351643 0
6 months post-randomisation.
Secondary outcome [8] 351644 0
Acceptability and feasibility of RCT 3) Number of children who change treatment group from original treatment allocation, as a proportion of enrolled children. Data will be collected from two sources: a) Australian Hearing appointment data for participants, which will include hearing aid fitting dates and appointment dates. b) Parent report in outcome survey, which includes questions about use of devices (age (years;months) of starting/stopping wearing hearing aids).
Timepoint [8] 351644 0
6 months post-randomisation.
Secondary outcome [9] 351646 0
Acceptability and feasibility of RCT 4) Device use - measured by automated data logging in hearing devices and parent report on proportion of device use during waking hours over the 6 months after fitting.
Timepoint [9] 351646 0
Monthly parent-report (survey) will collect usage during waking hours.
6 months post-randomisation, Australian Hearing appointment will collect data log from hearing aids.
Secondary outcome [10] 351647 0
Acceptability and feasibility of RCT 5) Acceptability of the RCT as reported by participant families and study clinicians (diagnostic and AH audiologists).
Parent report - questions included in the Outcomes Survey (Q 2.14 to 2.16).
Study clinicians - focus groups and interviews.

Timepoint [10] 351647 0
6 months post-randomisation.

Eligibility
Key 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 Australian Hearing (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 (21 to 40dB HL) across at least 3 frequencies over the range of 250 to 4000 Hz by objective or behavioural testing
5. Have pure sensorineural hearing loss
Minimum age
1 Months
Maximum age
2 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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. Pure Any conductive hearing loss
4. Hearing loss greater than 40 dB HL at any frequency at enrolment
5. Medical contraindication to hearing devices fitting
6. Families who definitively plan to move, during the following 6 months, to a location where follow-up assessment is not possible or practical

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment mechanism
A randomisation schedule will be generated by an independent statistician from the Clinical Epidemiology and Biostatistics Unit (CEBU) at the Murdoch Children’s Research Institute and uploaded to REDCap prior to any participant details being entered. REDCap will then assign each eligible participant to a group upon completion of enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Upon enrolment, families will be randomised using a 1 (hearing devices/intervention): 1 (no hearing devices/control) design. Randomisation will be stratified by child gender using block randomisation with a variable block size.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size Estimation
Given the incidence of mild bilateral hearing loss (0.4/1000 newborns; 37/35 were detected in Victoria alone in 2016/2017), approximately 100 infants will be eligible from all 3 states over one year. Anticipating a consent rate of 60% and a drop-out rate of 20%, approximately 48 children with mild bilateral hearing loss will be enrolled in the study over the study period of one year, with approximately 24 in each intervention arm.

Statistical Analysis Plan
Baseline data will be summarised by treatment group (as means and SDs or medians and IQRs for continuous variables and numbers and percentages for categorical variables). Outcomes for the primary aim and secondary aims 1 and 2 will be also be summarised by treatment group similarly to the baseline data, and will also be presented as the difference in means or proportions between the groups along with a 95% confidence interval. Outcomes for aim 3 will be presented descriptively.

Population to be analysed
We will conduct the analyses per-protocol population as this is a proof-of-concept study. The data will be used to design a larger RCT with adequate power to address the research questions.

Handling of missing data
We will exclude missing data from the analyses of mean differences between groups for the primary and secondary outcomes.

Methods of analysis
Baseline data will be summarised by treatment group (as means and SDs or medians and IQRs for continuous variables and numbers and percentages for categorical variables). Outcomes for the primary aim and secondary aims 1 and 2 will be also be summarised by treatment group similarly to the baseline data, and will also be presented as the difference in means or proportions between the groups along with a 95% confidence interval. Outcomes for aim 3 will be presented descriptively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 11699 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 23779 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 300464 0
Charities/Societies/Foundations
Name [1] 300464 0
Garnett Passe and Rodney Williams Memorial Foundation
Address [1] 300464 0
372-376 Albert St, East Melbourne VIC 3002
Country [1] 300464 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
50 Flemington Rd, Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 299934 0
None
Name [1] 299934 0
Address [1] 299934 0
Country [1] 299934 0
Other collaborator category [1] 280317 0
Other
Name [1] 280317 0
National Acoustic Laboratories
Address [1] 280317 0
Australian Hearing Hub, 16 University Ave, Macquarie Park NSW 2113
Country [1] 280317 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301267 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 301267 0
50 Flemington Rd, Parkville, VIC 3052
Ethics committee country [1] 301267 0
Australia
Date submitted for ethics approval [1] 301267 0
11/07/2018
Approval date [1] 301267 0
31/08/2018
Ethics approval number [1] 301267 0
38112A

Summary
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.
Trial website
https://www.mcri.edu.au/mildmatters
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 86426 0
Dr Valerie Sung
Address 86426 0
C/o Murdoch Children's Research Institute
50 Flemington Rd, Parkville, VIC 3052
Country 86426 0
Australia
Phone 86426 0
+61393454363
Fax 86426 0
+61393454363
Email 86426 0
valerie.sung@rch.org.au
Contact person for public queries
Name 86427 0
Dr Valerie Sung
Address 86427 0
C/o Murdoch Children's Research Institute
50 Flemington Rd, Parkville, VIC 3052
Country 86427 0
Australia
Phone 86427 0
+61393454363
Fax 86427 0
+61393454363
Email 86427 0
valerie.sung@rch.org.au
Contact person for scientific queries
Name 86428 0
Dr Valerie Sung
Address 86428 0
C/o Murdoch Children's Research Institute
50 Flemington Rd, Parkville, VIC 3052
Country 86428 0
Australia
Phone 86428 0
+61393454363
Fax 86428 0
+61393454363
Email 86428 0
valerie.sung@rch.org.au

No data has been provided for results reporting
Summary results
Not applicable