Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 98/39/02
Study information
Scientific title
Acronym
Study hypothesis
1. To determine by a prospective, longitudinal clinical trial the effectiveness and cost effectiveness of habilitation, including amplification, for children with mild to moderate hearing impairment.
2. To assess the appropriateness of earlier rather than later amplification in this group of children by randomly varying the age at which amplification is introduced into the habilitation. Major outcomes include acceptance, benefit and use of amplification, development of speech, language and communication, quality of life and quality of family life including social, emotional and behavioural aspects.
3. To determine the most cost-effective target criteria for the UK national universal neonatal hearing screening programme.
Strand 1: Qualitative workshops to determine
i. An agreed set of principles for the development of protocols for the clinical trial
ii. Current practice and beliefs of professionals and parents to refine the range of clinical equipoise necessary for an RCT in this area
iii. The best recruitment strategies for districts and families
iv. The best ways to provide family support using health and education services
v. Ways of minimising family anxiety about early screening and intervention
vi. Optimum early initial amplification fitting strategies and fine tuning procedures.
Strand 2: A clinical trial of intervention for mild to moderately hearing impaired children identified by neonatal screening with randomised allocation to groups 1-3 based on the age at which hearing aids are fitted (1=6 months, 2=11-13 months, 3=17-19 months) compared with comparison groups 4-6 (4=mild to moderate hearing impaired detected at 24-36 months, 5=moderate hearing impaired children detected and aided early, 6=normal hearing). The trial will be carried out at children's hearing services in UK districts using targeted or universal neonatal hearing screening.
Details of this study can also be found at: http://www.hta.ac.uk/project/1238.asp
Please note that, as of 17 January 2008, the start and end date of this trial have been updated from 1 April 2000 and 1 April 2005 to 1 April 2001 and 31 October 2007, respectively.
Ethics approval
Not provided at time of registration.
Study design
Longitudinal clinical trial
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Screening
Patient information sheet
Condition
Ear, nose and throat diseases
Intervention
An intervention package for children with mild to moderate hearing impairment will be assessed for appropriateness, effectiveness and cost effectiveness. The package has two components:
i. Quality family support, including personal support and an information package on hearing loss and language development (in written and video form)
ii. Appropriate amplification at an age that is randomly assigned in the region of clinical equipoise.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The societal costs (direct and indirect) associated with the different interventions will be estimated together with the associated benefits in terms of quality of life (including quality of family life and detailed behavioural and emotional aspects of development). The major outcomes assessed on 4 occasions (ages 9-12, 15-18, 21-24 months and final visit) will be (i) compliance with amplification, (ii) expressive and receptive speech and language (iii) QoL for child and family and (iv) behavioural and emotional measures. Costs will be estimated in a similar way to those in our present studies assessing outcomes in UK children who have had a cochlear implant or a hearing aid.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/04/2001
Overall trial end date
31/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Children identified with permanent mild or moderate hearing impairment by neonatal screening.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/04/2001
Recruitment end date
31/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Institute of Hearing Research
Nottingham
NG7 2RD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary