The Effect of Early Non-Surgical Treatment of Children With Middle Ear Effusion on the Hearing Level and the Health Economics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Change from Baseline (start of treatment in the treatment group or start of control in the control group) in Hearing Level measured using age suitable audiogram.
研究概览
简要总结
Secretory otitis media (SOM) or middle ear effusion is a common finding after acute otitis media (AOM). It is usually associated with 5-15 deci Bells hearing loss. Although spontaneous resolution with normalisation of hearing is the usual outcome, this can take several months. Secretory otitis media is the most common cause of hearing impairment in the paediatric age group. When the hearing loss caused by SOM is bilateral and persists for 3-6 months or more, surgery with tympanostomy tube insertion under general anaesthesia is indicated. In Sweden, 10000 children undergo this operation annually. Although many children with unilateral or bilateral SOM improve in the summer, the problem usually recurs in the autumn or winter. The cost of SOM for the Swedish society was 600 million Swedish crowns 2005.
In two previous studies, the investigators concluded that the nonsurgical treatment method, that was developed to assist children with SOM equalising their middle ear pressure, could normalise the hearing level in 80 % of children with SOM of minimum duration of 3 months. These children avoided therefore grommet insertion.
The investigators would like to assess the effect of this new treatment method on hearing directly after AOM. The investigators expect that using the new method could rapidly normalise hearing in these cases and thereby operation with grommet insertion could be avoided.
详细描述
Background:
Secretory otitis media (SOM) or middle ear effusion is the most common cause of hearing impairment in children. Hearing loss occurs due to the accumulation of fluid in the middle ear. In most of the cases, SOM follows acute otitis media (AOM). In cases when the SOM is bilateral and persists for more than 3-6 months, operation with grommet insertion under general anaesthesia is indicated. 10000 children with SOM are operated with grommet insertion every year in Sweden. In cases of unilateral hearing loss caused by SOM, grommet insertion is rarely indicated if the duration of symptoms is less than one year. Some patients develop persistent perforation in the eardrum after extrusion of the tympanostomy tube.
A new method of middle ear pressure equalisation has been developed at the Sahlgrenska University Hospital. 45 children in the age of 2-8 years with SOM that persisted for more than 3 months had been treated with this new method under the waiting period for grommet insertion. 80% of these children had been cured with regaining of normal hearing and avoided operation. No complication/side effects were noticed and the compliance was good.
Aim of the study:
To assess the effectivity of the new nonsurgical treatment method for equalisation of middle ear pressure in rapid regaining of hearing after acute otitis media in 2,5-7 years old children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral middle ear effusion with resultant conductive hearing loss one week after acute otitis media.
- •Intact tympanic membranes bilaterally.
- •Acceptable level of written and spoken swedish language skills.
排除标准
- •Comorbidity,
- •Perforated acute otitis media or other complications of acute otitis media.
结局指标
主要结局
Change from Baseline (start of treatment in the treatment group or start of control in the control group) in Hearing Level measured using age suitable audiogram.
时间窗: Three months after baseline.
Measuring hearing threshold using age suitable audiogram.
次要结局
- Change from Baseline in Middle Ear Pressure measured using tympanogram.(One week, one month and three months after baseline.)
- Number of Health Care or Hospital Visits due to Ear Associated Problems.(Three months after baseline.)
- Presence of Fluid in the Middle Ear.(One week, one month and three months after baseline.)
- Health Economics Measured Mainly by the Number of Parental Leave Days which the parent/parents needed to take in order to look after the child.(Three months after baseline.)
- Otitis Media Questionnaire-14 (OMQ-14).(Three months after baseline.)