Autoinflation: Alternative in the Treatment of Otitis Media With Effusion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Otitis media with effusion resolution proven with normalization of results in the audiological study (tympanogram and audiogram)
研究概览
简要总结
Otitis media with effusion (OME) is a common finding affecting children and the main cause of acquired hearing loss in the pediatric age.
OBJECTIVES
The purpose of the clinical study is to determine whether self-inflation using a new device:
- It is an effective non-invasive treatment during the watchful waiting period, with the ability to improve hearing loss and prevent surgical treatment;
- Maintains long-term hearing improvement;
详细描述
- Introduction
Otitis media with effusion (OME) is a common finding affecting children in the age of 2-6 years. Although OME is the main cause of acquired hearing loss in the pediatric age, it's treatment it's still controversial. Due to high spontaneous resolution, current international guidelines recommend a period of "watchful waiting" for 3 to 6 months after which, if the hearing loss persists, surgery with tympanostomy tube insertion under general anesthesia is indicated.
During the watchful waiting period, medical treatment options, such as oral and nasal corticosteroids, antibiotics, mucolytics or nasal decongestants, are not recommended due to lack of effect or side effects. Nevertheless, the results of autoinflation in the treatment of OME in children are divergent although suggestive of clinical effect in the short-term.
In a previous study the authors concluded that autoinflation with a new device - Moniri® Medical Device - resolved the OME and prevented surgery in 80% of children with chronic OME.
In this study, the authors developed a new standardized, inexpensive and simple device, based on Moniri® Medical Device. The Device is formed by a T tube with a unidirectional valve. A mask with the capacity of covering the child's mouth and nose, providing hermetic seal, and a balloon are connected to 2 ends of the T tube. Blowing the balloon trough the mask, with different types of maneuvers, will force the opening of the Eustachian tube and subsequent reabsorption of the middle ear effusion. 2. Aime Our aim it's to prove that autoinflation is an efficient non-invasive treatment during the watchful waiting period, with the capacity of improving hearing loss thus preventing surgical treatment. 3. Material and Methods
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria: Children between 3 and 8 years of age with otomicroscopic alterations suggestive of unilateral or bilateral OME; type B or C2 tympanogram (pressure ≤ 200 daPa); audiogram with hearing loss ≥ 20 dB or air-bone gap at the time of evaluation by an otolaryngologist.
排除标准
- •Children with uncontrolled asthma, craniofacial anomalies, active ear disease (retraction pouch, adhesive otitis or tympanic perforation) or a history of ear surgery.
结局指标
主要结局
Otitis media with effusion resolution proven with normalization of results in the audiological study (tympanogram and audiogram)
时间窗: 3 years
Outcomes assessed by sustained improvement in the audiological study carried out with the following complementary diagnostic tests: audiogram and tympanogram
次要结局
未报告次要终点
研究者
Joao Lino
Principal Investigator
Instituto de Ciências Biomédicas Abel Salazar