Interventions for mild to moderate permanent childhood hearing impairments identified by neonatal hearing screening

ISRCTN	ISRCTN74171163
DOI	https://doi.org/10.1186/ISRCTN74171163
Secondary identifying numbers	HTA 98/39/02

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 24/07/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Adrian Davis
Scientific

MRC Institute of Hearing Research
University Park
University of Nottingham
Nottingham
NG7 2RD
United Kingdom

Phone	+44 (0)161 275 8821

Study information

Study design	Longitudinal clinical trial
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Other
Study type	Screening
Scientific title
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2001
Completion date	31/10/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	Not provided at time of registration.
Key inclusion criteria	Children identified with permanent mild or moderate hearing impairment by neonatal screening.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/04/2001
Date of final enrolment	31/10/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

MRC Institute of Hearing Research

Nottingham
NG7 2RD
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan