The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Sleep apnea questionnaire
研究概览
简要总结
The purpose of this study is to investigate the effect of treatment with a steroid and antibiotic on the size of the tonsils and symptoms of children with OSAS.
详细描述
We will enroll children between 18 months and 12 years of age with mild sleep apnea and treat them with 5 days of prednisolone and 10 days of amoxicillin/clavulanate. We will obtain a questionnaire pre and post treatment and ask the parents to tell us if they think the child has improved enough after treatment to forego surgery. If not, they will undergo an adenotonsillectomy to relieve their sleep apnea and if yes, we will repeat the sleep study to make sure that the apnea has resolved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polysomnogram results showing mild obstructive sleep apnea.
排除标准
- •Significant medical problems
- •Chronic medication intake (except bronchodilators and inhaled steroids)
- •Allergy to penicillin or its derivatives.
结局指标
主要结局
Sleep apnea questionnaire
时间窗: 1-2 weeks post treatment
Size of tonsils
时间窗: before and after treatment
次要结局
未报告次要终点