CHILD DEVELOPMENT IN RELATION TO EARLY OTITIS MEDIA

与早期中耳炎相关的儿童发育

• 批准号: 2199830
• 负责人: JACK L PARADISE
• 金额: $ 231.08万
• 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/2199830
• 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)本申请是一份 第二次修订最初于1988年9月提交，并于 九月，。这项研究的目的是确定：(1) 渗出性中耳炎(OME)是否发生在常见的 生命头三年的频率和持续时间导致持久 言语、语言、认知和心理社会发展方面的障碍； (2)即刻鼓室切开置管(TTP)是否有效 防止或减轻损害。提出了两个无效假设： (1)第一次OME累计持续时间较短的儿童 三年的生命可以在一定年龄的特定测试中取得分数。 3到7岁，并不比孩子们的分数更有利 具有更长的OME累积持续时间(在指定的上限内) 在生命的前三年；(2)患有OME的儿童在 接受鼓室切开置管治疗的婴儿的前三年 (TTP)，如果随机分为两组，则接受：(A)提示TTP； 或(B)延迟的TTP将显示某些指定测试的分数，这些测试 TTP组与TTP组之间无显著差异。 总共5338名两个月以下的健康婴儿将被 参加为期21个月的前瞻性研究。中耳状况 将在生命的头两年每月监测一次，每两个月监测一次 在第二年和之后的每季度通过鼓室导纳 和气动耳镜检查。听力水平将在年每月监测一次 患有渗出性持续性中耳炎的儿童。孩子们 在前三年内满足持久性OME的特定标准 在父母同意的情况下，LIFE将被随机分配接受TTP 立即(早期TTP)或在定义的时间段之后(如果OME仍然存在) 当前(延迟TTP)。将对所有人的发展成果进行评估 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、认知和心理社会发展 将在所有早期TTP和晚期TTP受试者中进行评估，并在 其余受试者在3岁、4岁、5岁、6岁和7岁时使用标准化测试。