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
Completed
- Conditions
- Hearing researchEar, Nose and ThroatGlue ear
- Registration Number
- ISRCTN35793977
- Lead Sponsor
- Medical Research Council (MRC) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 590
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method