WATER PRECAUTIONS AND TYMPANOSTOMY TUBES

水注意事项和鼓膜造口管

• 批准号: 6115530
• 负责人: ELLEN M MANDEL
• 金额: $ 2.06万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6115530
• 关键词: antibiotics; child (0-11); clinical research; disease /disorder prevention /control; diving /swimming; ear infection; ear surgery; exudate /transudate; human subject; human therapy evaluation; microorganism culture; otitis media

Children with tympanostomy tubes have traditionally been advised to protect their ears when swimming and bathing. Although acute otorrhea through a patent tube is a common occurrence, there is no published evidence that water exposure is causative. We will prospectively randomize 300 children, ages 6 months to 6 years, who have had bilateral tympanostomy tubes placed within one month of entry to one of 2 groups: 1) swimming and bathing without earplugs or 2) swimming and bathing with earplugs. We will stratify the groups by age (<4 years, > 4 years) and by diagnosis (recurrent acute otitis media, otitis media with effusion). Parents will be given a calendar to record all swimming and bathing activity. The children will be seen monthly for one year, and whenever there is an intercurrent ear, nose, or throat problem. If otorrhea develops, a culture will be performed and the child will be treated with an oral antibiotic and ototopical drops. The primary comparison will be the incidence of otorrhea in each experimental group and the second comparison will be the average number of episodes per child in the two groups. Examination of the culture results will help determine the pathogenic mechanisms responsible for the otorrhea.

传统上，建议使用鼓膜造口管的儿童在游泳和沐浴时保护耳朵。 尽管通过专利管急性耳开是常见的情况，但尚无公开的证据表明水暴露是病因。 我们将前瞻性地将300名6个月至6岁的儿童随机分配，他们的双侧鼓膜造口管在一个月内放置在2组中的一个月内：1）没有耳塞的游泳和洗澡或2）带有耳塞的游泳和洗澡。 我们将根据年龄（<4岁，> 4年）和诊断（复发性急性中耳炎，有积液的中耳炎）对组进行分层。 父母将获得一个日历，以记录所有游泳和沐浴活动。 每月都会看到孩子们一年，每当有互相的耳朵，鼻子或喉咙问题时。 如果发达耳开裂，将进行培养物，并将用口服抗生素和耳型滴剂对孩子进行治疗。 主要比较将是每个实验组的耳漏的发生率，第二个比较将是两组中每个儿童发作的平均发作数。 对培养结果的检查将有助于确定导致耳开的致病机制。