EARLY OTITIS AND LITERACY AND ATTENTION AT 9 TO 11 YEARS

本研究将调查儿童在生命的前3年内持续性渗出性中耳炎（OME）是否会导致9至11岁儿童的读写能力、注意力或相关技能的损害，如果是，及时放置鼓室造口管（TTP）是否能有效预防或减轻此类损害。 这项研究建立在目前的一项研究基础上，该研究评估了3岁、4岁和6岁时早期持续性中耳积液、TTP与言语、语言、认知和心理社会发展之间的关系。 在这项研究中，6350名2个月大的正常婴儿的不同样本被招募，他们的中耳状况被前瞻性地集中监测。 来自当前研究的三个受试者队列将构成拟定研究的受试者。 一个队列包括429名儿童，他们在出生后的前3年内持续了指定时间的延长期，并在此基础上被随机分配接受即时TTP，或在指定时间后延迟TTP，如果他们的持续期。 第二个队列包括152名符合随机化标准但父母不允许随机化的儿童。 第三个队列包括241名入选儿童的样本，这些儿童的范围从出生后3年内没有发生过癫痫到仅满足随机化标准的癫痫持续时间不等。 迄今为止的研究结果表明，在研究的持续时间范围内，在这些队列中测量的3岁和4岁的发育结果没有可测量的影响。 尽管如此，在9岁、10岁或11岁时对三个队列进行发展评估是重要的，原因有四：（1）目前，推荐幼儿进行TTP的官方指南部分基于以下报告：早期生活中的持续性焦虑会导致儿童达到学龄时识字、注意力和相关技能的损害。 然而，有关研究有重要的局限性，其结果值得怀疑。(2)在我们目前的研究中，在3岁或4岁时不明显的关系可能在以后的年龄变得明显。(3)我们目前的研究在6岁时结束，不包括识字或注意力能力的测量。(4)这3个队列构成了一个有价值的和独特的研究人群，只能以高昂的成本进行复制。 拟议的研究将提供新的知识，使中耳炎的管理更加合理，以证据为基础，从而使儿童受益，并大大影响儿童卫生保健的做法和成本。

This study will investigate whether persistent otitis media with effusion (OME) during children's first 3 years of life results in impairments at ages 9 to 11 years of their literacy, attentional abilities, or related skills, and if so, whether prompt tympanostomy-tube placement (TTP) is efficacious in preventing or lessening such impairments. The proposed study builds on a current study that assesses relations between persistent middle-ear effusion (MEE) in early life, TTP, and speech, language, cognitive, and psychosocial development at ages 3, 4, and 6 yr. In that study, a diverse sample of 6350 normal infants was enrolled by age 2 months and their middle-ear status was intensively monitored prospectively. Three cohorts of subjects from the current study will constitute the subjects of the proposed study. One cohort consists of 429 children in whom MEE had persisted for extended periods of specified duration during the first 3 years of life and who on that basis were randomly assigned to receive either prompt TTP, or delayed TTP after a specified period if their MEE persisted. The second cohort consists of 152 children who met the criteria for randomization but whose parents withheld permission for randomization. The third cohort consists of a sample of 241 enrolled children who represented a spectrum ranging from no MEE in the first 3 years of life to having durations of MEE just short of meeting the randomization criteria. Findings to date indicate no measurable impact of MEE, within the duration limits studied, on the developmental outcomes measured in these cohorts at ages 3 and 4 years. Nonetheless, developmental assessment of the three cohorts at age 9, 10, or 11 yr is important for 4 reasons: (1) Current, official guidelines recommending performance of TTP in young children are based, in part, on reports that persistent MEE in early life results in impairments of literacy, attentional abilities, and related skills when children reach school age. However, the studies concerned have had important limitations and their results are questionable. (2) Relations that were not apparent in our current study at ages 3 or 4 might become apparent at later ages. (3) Our current study, which ends at age 6 yr, does not include measures of literacy or attentional abilities. (4) The 3 cohorts constitute a valuable and unique population for study that can be replicated only at great cost. The proposed study will provide new knowledge that will make possible more rational, evidence-based management of otitis media, and thereby benefit children and substantially influence child health care practices and costs.