Condition category
Ear, Nose and Throat
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
24/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Adrian Davis

ORCID ID

Contact details

MRC Institute of Hearing Research
University Park
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
+44 (0)161 275 8821

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

http://www.dh.gov.uk/en/index.htm

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

Publication citations

Additional files

Editorial Notes