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ISRCTN
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ISRCTN74171163
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ClinicalTrials.gov identifier
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Public title
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Interventions for mild to moderate permanent childhood hearing impairments identified by neonatal hearing screening
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 98/39/02
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Longitudinal clinical trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ear, nose and throat diseases
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Participants - inclusion criteria
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Children identified with permanent mild or moderate hearing impairment by neonatal screening.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/04/2001
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Anticipated end date
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31/10/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration.
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Prof
Adrian
Davis
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Address
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MRC Institute of Hearing Research
University Park
University of Nottingham
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City/town
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Nottingham
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Zip/Postcode
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NG7 2RD
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Country
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United Kingdom
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Tel
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+44 (0)161 275 8821
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Email
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acd@ihr.mrc.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Tel
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+44 (0)1132 545 843
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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04/09/2009
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Date ISRCTN assigned
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25/04/2003
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