ISRCTN50641733已完成不适用
The efficacy of nasal cavity lavage with a physiological saline solution in prevention of recurrent acute otitis media: a pilot randomised controlled study
Sainte-Justine Hospital Research Centre (Centre de recherche du CHU Sainte-Justine) (Canada)0 个研究点目标入组 40 人开始时间: 2008年4月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age is between 6 months and 5 years old (exclusively), either sex
- •2. Recurrent acute otitis media (AOM) (diagnosed by paediatrician or referring general practitioner):
- •2.1. Four AOM within 6 months
- •2.2. Six AOM or more within 1 year
排除标准
- •1. Parents refuse to participate
- •2. Known disease or syndrome modifying the normal anatomy or physiology or the upper respiratory tract (Downs, Apert, Crouzon, mucopolysaccharidosis, cranio-cerebral trauma, etc.)
- •3. Malformations:
- •3.1. Craniofacial, skull base or nose
- •3.2. Complete or submucous cleft palate
- •4. Immunodeficiency:
- •4.1. Congenital (according to paediatrician or immunologist)
- •4.2. Acquired (human immunodeficiency virus [HIV], chemotherapy)
- •5. Ciliary dysfunction (according to paediatrician or pneumologist)
- •6. Tympanic membrane perforation
- •7. Cholesteatoma
- •8. Acute complication of AOM (intra- or extra-cranial)
- •9. History of ear, nose and throat (ENT) surgery (adenoidectomy, tonsillectomy, myringotomy or other)
- •10. Intra-nasal or systemic corticosteroid use (pulmonary steroids not excluded)
- •11. Adenoid or tonsil hypertrophy with suspicion of obstructive apnoea
- •12. Multiple allergies to antibiotics
- •13. Insufficient comprehension of written or spoken French by parents
研究者
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