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 个研究点目标入组 294 人开始时间: 2011年6月16日最近更新: 2016年10月17日

研究概览

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•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.

•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

发起方

niversity of Southampton (UK)