Analysis of Clinical, Pathologic and Molecular Markers of Adenotonsillar Hypertrophic Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Bioclinical profile of adenotonsillar hypertrophy
研究概览
简要总结
Adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood, yet little is known with regard to its pathophysiologic and molecular mechanisms. The present trial examines potential bioclinical markers of the disease.
详细描述
Background: Tonsils and adenoids comprise the main bulk of Waldeyer's ring, which is commonly enlarged in childhood, until the age of 11. Obstructive sleep apnea caused by adenotonsillar hypertrophy is a major contributing factor to cardiorespiratory morbidity in the pediatric population. It is also responsible for otitis media with effusion, the most frequent cause of children's hearing loss. Even so, there is scarce knowledge of its molecular pathogenesis.
Objective
Identification of clinical/molecular markers of adenotonsillar enlargement and investigation of their participation in the process of tissue hypertrophy.
Methods: A prospective cohort of children with adenotonsillar hypertrophy were recruited starting on 02/01/2017 and ending on 12/22/2017. Demographic and clinical data including age, gender, sleep apnea severity, tonsillar size, presence of middle ear effusion, family history, review of systems as well as tympanometric and complete blood count results were recorded. Blood samples and tissue specimens from the therapeutic adenotonsillectomy procedure were archived for future analyses. Children with chronic tonsillitis and/or adenoiditis, who also underwent excision of tonsils and/or adenoids served as study controls. Informed consent was obtained from parents of all study participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Available history and physical exam findings
- •Available complete blood count and tympanometry at admission
排除标准
- •Previous tonsillectomy and/or adenoidectomy.
- •Previous ear surgery.
- •Acute infection during the past month.
- •Active severe systemic disease.
结局指标
主要结局
Bioclinical profile of adenotonsillar hypertrophy
时间窗: One year post surgical procedure
Clinical, laboratory, and molecular markers of adenotonsillar hypertrophy
次要结局
- Laboratory markers of adenotonsillar hypertrophy(One year post surgical procedure)
- Clinical markers of adenotonsillar hypertrophy(One year post surgical procedure)
- Wide-Band tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy(One year post surgical procedure)
- Molecular determinants of adenotonsillar hypertrophy(One year post surgical procedure)
- Tympanometric findings of middle ear disease resulting from adenotonsillar hypertrophy(One year post surgical procedure)
研究者
Georgios Stathopoulos
Associate Professor of Physiology
University of Patras