CHILD DEVELOPMENT IN RELATION TO EARLY OTITIS MEDIA

与早期中耳炎相关的儿童发育

• 批准号: 3327371
• 负责人: JACK L PARADISE
• 金额: $ 216.25万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-06-01 至 1996-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3327371
• 关键词: audiometry; child physical development; clinical trials; cognition; diagnosis design /evaluation; ear disorder diagnosis; early diagnosis; hearing; hearing tests; human subject; human therapy evaluation; infant human (0-1 year); middle ear; otitis media; preschool child (1-5); social psychology; speech; tympanoplasty

DESCRIPTION: (Adapted From The Applicant's Abstract) This application is a second revision originally submitted on September, 1988 and resubmitted on September, 1989. The objectives of this study are to determine: (1) whether otitis media with effusion (OME) occurring at common levels of frequency and duration during the first three years of life causes lasting impairments in speech, language, cognitive and psychosocial development; and (2) whether prompt tympanotomy-tube placement (TTP) is efficacious in preventing or lessening the impairments. Two null hypotheses are proposed: (1) that children with lesser cumulative durations of OME during the first three years of life will achieve scores on certain designated tests at ages 3 through 7 years which are no more favorable than the scores of children with greater cumulative durations of OME (within specified upper limits) during the first three years of life; (2) that children with OME during the first three years of life who are managed with tympanotomy-tube placement (TTP), if divided randomly into two groups which receive: (a) prompt TTP; or (b) delayed TTP will show scores on certain designated tests which are not significantly different between the two TTP groups. A total of 5,338 healthy infants less than two months of age will be enrolled in a prospective study over a 21-month period. Middle ear status will be monitored monthly during the first two years of life, bimonthly during the second year and quarterly thereafter by means of tympanometry and pneumatic otoscopy. Hearing levels will be monitored monthly in children who develop persistent otitis media with effusion. Children who meet specific criteria for persistent OME during the first three years of life will, subject to parental consent, be randomly assigned to receive TTP either promptly (early TTP) or after a defined period if OME is still present (late TTP). Developmental outcomes will be assessed in all subjects at ages 2 months, 1 year and 2 years through standardized questionnaires. Speech, language, cognitive and psychosocial development will be assessed in all early TTP and late TTP subjects and in a sample of remaining subjects at ages 3, 4, 5, 6 and 7 years using standardized tests.

描述：（改编自申请人的摘要）此应用程序是一个 第二次修订最初于 1988 年 9 月提交，并于 2017 年重新提交 1989 年 9 月。本研究的目标是确定：(1) 渗出性中耳炎 (OME) 是否常见于 生命前三年的频率和持续时间会导致持久 言语、语言、认知和社会心理发展障碍； (2) 立即置入鼓室置管 (TTP) 是否有效 预防或减轻损伤。 提出了两个零假设： (1) 在第一次治疗期间 OME 累积持续时间较短的儿童 生命中的三年将在某些年龄的指定测试中取得分数 3到7岁不比孩子的成绩更优惠 具有更大的 OME 累积持续时间（在指定上限内） 在生命的头三年； (2) 患有 OME 的儿童 接受鼓室置管治疗的生命前三年 (TTP)，如果随机分为两组，则接收： (a) 提示 TTP； (b) 延迟 TTP 将显示某些指定测试的分数，这些测试是 两个 TTP 组之间没有显着差异。 总共 5,338 名两个月以下的健康婴儿将被 参加了一项为期 21 个月的前瞻性研究。 中耳状态 在生命的头两年中每月进行一次监测，每两个月一次 在第二年和此后每季度通过鼓室导抗测试 和气动耳镜检查。 每月将监测听力水平 患有持续性渗出性中耳炎的儿童。 儿童谁 在前三年内满足持续性 OME 的具体标准 经父母同意，生命将被随机分配接受 TTP 立即（早期 TTP）或在规定的时间后（如果 OME 仍然存在） 目前（TTP 后期）。 发展成果将在所有方面进行评估 2个月、1岁和2岁的受试者通过标准化 问卷调查。 言语、语言、认知和社会心理发展 将在所有早期 TTP 和晚期 TTP 受试者以及样本中进行评估 使用标准化测试对 3、4、5、6 和 7 岁的其余受试者进行测试。