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，鼓室造瘘管的儿童在游泳和洗澡时都被建议保护他们的耳朵。虽然通过开放的导管发生急性耳漏是一种常见的情况，但没有公开的证据表明水暴露是导致耳漏的原因。我们将300名年龄在6个月到6岁之间、在入院后一个月内放置双侧鼓室造瘘管的儿童随机分为两组：1)游泳和洗澡不戴耳塞；2)游泳和带耳塞洗澡。我们将根据年龄(4岁，4岁)和诊断(复发性急性中耳炎、渗出性中耳炎)对患者进行分层。家长将获得一份日历，记录所有游泳和洗澡活动。孩子们将在一年的时间里每月看一次面，每当耳朵、鼻子或喉咙同时出现问题时。如果出现耳漏，将进行培养，并使用口服抗生素和耳滴剂进行治疗。第一次比较将是每个试验组的耳漏发生率，第二次比较将是两组每个儿童的平均发作次数。对培养结果的检查将有助于确定耳漏的致病机制。