ISRCTN55208702CompletedNot Applicable
An open randomised study of autoinflation in 4-11 year old school children with otitis media with effusion (OME) in primary care
niversity of Southampton (UK)0 sites294 target enrollmentStarted: June 16, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 294
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Aged 4-11 years and attending school at the time of the first planned tympanometric screen (To be able to reliably perform the technique and have a greater theoretical chance of cure)
- •2. A relevant notes recorded history of recent and/or recurrent otitis media symptoms (defined as within the last year) or ear related problems in the previous year (e.g. suspected hearing loss, slow speech development etc), or a guardian denotes a concern in one or more OME related symptom domains on the screening invitation letter symptom check list (in the targeted 4 to 7 years of age and seasonal high risk of OME groups)
- •3. Tympanometric confirmation in a child of at least one B tympanogram (using the modified Jerger classification). This has an approximate 90% positive predictive value of an effusion being present i.e. cases of unilateral or bilateral OME.
Exclusion Criteria
- •1. Children who need early referral as judged clinically, to include those known rarer cases with high risk of recurrence: Down's syndrome, cleft palate, kartagener's syndrome, primary ciliary dyskinesia, immunodeficiency states, etc.
- •2. Four year old children not attending school at the time of screening, or children deemed by the nurse unable to comply with the technique of autoinflation
- •3. At study entry, children with a grommet already in place in an ear drum, or where the child has been referred or listed for ear surgery
- •4. Latex allergy (balloons are latex)
- •5. A recent nose bleed in the past three weeks or more than one episode of nose bleeding over the past 6 months
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