Trial of alternative regimens in glue ear treatment - effectiveness of surgery for otitis media with effusion in 3.5-7 year olds using multiple developmental and economic measures combined with classical clinical measures

ISRCTN	ISRCTN35793977
DOI	https://doi.org/10.1186/ISRCTN35793977
Protocol serial number	E203/85
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof MP Haggard
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TRIAL
Study objectives	To assess the benefit of the three main treatments for Otitis Media with Effusion (OME), i.e. Ventilation tube insertion alone, Ventilation tube insertion plus adenoidectomy, Observation + medical management- in terms of: 1. The impact upon the child's life including hearing ability, general health, behaviour and quality of life 2. The relative cost effectiveness of treatment to the NHS particularly in terms of additional benefit conferred by adenoidectomy
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Hearing research
Intervention	1. Ventilation tube insertion alone 2. Ventilation insertion plus adenoidectomy 3. Observation + medical management
Intervention type	Other
Primary outcome measure(s)	Clinical measures - Otoscopy, audiometry, tympanometry and questionnaire measures, (hearing and predictive factors, general health, economic impact, behavioural assessment and quality of life)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/1997

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target sample size at registration	590
Key inclusion criteria	Children aged 3.5-7 years having had no previous ear or adenoid surgery, having B+B or B+C2 tympanograms and a bilateral average hearing threshold greater than 20 dB, plus an air-bone gap greater than 10 dB HL.
Key exclusion criteria	Children with severe general disease, cranio-facial abnormalities, sensori-neural losses, parents with language or literacy problems. A few children are also excluded if a consultant feels it would be unethical to randomise them into the study.
Date of first enrolment	01/04/1994
Date of final enrolment	01/12/1997

Institute of Hearing Research

Nottingham
NG7 2RD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2012		Yes	No
Protocol article	protocol	01/10/2001		Yes	No