The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 主要终点
- Clinical examination:Hearing loss
研究概览
简要总结
Otitis media with effusion (OME) is defined as effusion in the middle ear without signs and symptoms of an acute infection. It is a leading cause of hearing impairment in children, and its early and proper management can avoid hearing and speech impairment, which can cause developmental delay in children.Although many conditions such as enlarged adenoids, cleft palate, Down syndrome, Kartagener syndrome, and nasopharyngeal neoplasm are related to the role of eustachian tube (ET) dysfunction in the pathogenesis of OME, allergic, immunologic, and infectious factors have also been claimed. Treatment of OME is still a controversial issue, as conventional treatment approaches fail to provide satisfactory and permanent relief of otologic symptoms.There is lack of proven effectiveness of the commonly given treatments, such as antibiotics, decongestants, and antihistamines, which are potentially harmful and have disadvantages. Few in those studies,investigated topical intranasal steroid for OME treatment,and in those studies, the duration of intranasal steroid application was short and there was no hearing evaluation.
详细描述
The aim of this study is to assess the efficacy of nasal steroids in management of OME by comparing its results with that of oral steroids and that of nasal saline spray.
Sixty patients (4-12) years aged children with OME over a period for two months will be included in this study. Informed written consent will obtained from the parents of patient studied after explanation of the research purpose.
Patient diagnosed clinically to have OME with type B tympanogram and conductive hearing loss will be enrolled in our study.
Exclusion criteria:
- Patients previously managed by ventilation tube.
- Those who had cleft palate. The patients were divided into three equal groups. In group 1, 20 patients will be received steroids spray, for. 2 months In group 2, 20 patients will be received steroids for 1 month In group 3, 20 patients will be receive hypertonic sea water solution Otoscopic examination, basic audiological evaluation including pure tone audiometry, and immittancemetry will be performed before treatment and repeated at 3 and 6 months after treatment. The evaluation was performed using ORBITR 922 VERSION2 . Examiners will be blinded to the type of treatment.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sixty patients (4-12) years aged children with OME over a period for two months.
排除标准
- •Patients previously managed by ventilation tube.
- •Those who had cleft palate.
研究组 & 干预措施
momestone furoate spray first group: will be given
Nasonex spray one puff in each nostril daily for 8 weeks
干预措施: Mometasone Furoate spray (Drug)
prednisolone sodium phosphate 15mg second group: will be given
Predsol fort tablet three times per day for 1 week then gradual withdrawal over 2 weeks
干预措施: prednisolone sodium phosphate 15mg (Drug)
hypertonic sea water solution spray third group: will be given
Nasal spray one puff in each nostril daily for 8 weeks
干预措施: hypertonic sea water solution spray (Drug)
结局指标
主要结局
Clinical examination:Hearing loss
时间窗: 2 weeks evaluation for 2 months
Hearing loss,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,
Clinical examination:Nasal obstruction
时间窗: 2 weeks evaluation for 2 months
Nasal obstruction,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,
Full E.N.T history
时间窗: 2 weeks evaluation for 2 months
Snoring ,sleep apnea ,difficult suckling in infants,anterior nasal discharge and conductive hearing loss.
次要结局
未报告次要终点
研究者
Muteea Mubark Salmen Bakuwiri
Principal Investigator
Assiut University