Early Otitis and Literacy and Attention at 9 to 11 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- All measures at 9 to 11 years of age:
研究概览
简要总结
Middle-ear disease (infection and fluid) is the most common illness in young children after the common cold. Because hearing loss accompanies middle-ear disease, and because early life is a period of rapid development, concern has existed that sustained periods of middle-ear disease might cause lasting impairments of learning, speech development, language development, or behavior and social adjustment. Earlier phases of this research found that the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear disease did not affect their development at 3, 4, or 6 years of age. This study examines the children's literacy, attention, and related abilities at 9 to 11 years of age.
详细描述
Concern has long existed that persistent otitis media in young children, because of the associated conductive hearing loss, can result in lasting impairments of the children's development. Accordingly, myringotomy with insertion of tympanostomy tubes has often been undertaken in such children in order to promptly restore hearing to normal. However, evidence concerning developmental effects of persistent early-life otitis media has been inconclusive, and evidence that tube insertion in affected children influences their development favorably has been lacking. From a previous study we reported that among a cohort of children younger than three years of age with persistent effusion, prompt as compared with delayed insertion of tympanostomy tubes did not result in improved developmental outcomes in the children at three, four, and six years of age. The purpose of the present study was to assess developmental outcomes in the same children at nine to eleven years of age.
Beginning in 1991, we enrolled 6350 healthy infants less than 62 days of age and evaluated them at least monthly until they reached three years of age. We randomly assigned 429 of the children who developed persistent middle-ear effusion before reaching that age to have tympanostomy tubes inserted either promptly or up to nine months later if effusion persisted. At three, four, and six years of age we systematically assessed the children's cognitive, language, speech, and psychosocial development. In the present study, using a standardized battery of assessments, we evaluated literacy, attentional abilities, social skills, and academic achievement in 391 of these children at nine to eleven years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 0 Years 至 61 Days(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, less than 62 days of age at enrollment
排除标准
- •birth weight less than 5 lb (2268 g)
- •small for gestational age
- •history of neonatal asphyxia or other serious illness
- •major congenital abnormality or chronic illness
- •multiple birth
- •sibling enrolled in the study
- •in foster care or adopted before enrollment
- •mother dead, seriously ill, a known drug or alcohol abuser before enrollment
- •mother judged by study personnel to be too limited socially or intellectually to give informed consent or adhere to the study protocol
- •mother less than 18 years of age
- •English not the only household language
结局指标
主要结局
All measures at 9 to 11 years of age:
Woodcock Reading Mastery Tests-Revised-Normative Update
Number of words in a grade-level passage read correctly in one minute
Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery
Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing
Children's version of the Hearing in Noise Test
Disruptive Behavior Disorders Rating Scale
Child Behavior Checklist, parent report
Child Behavior Checklist, teacher report
Impairment Rating Scales, parent report
Impairment Rating Scales, teacher report
Computerized visual continuous performance test
Computerized auditory continuous performance test
Wechsler Abbreviated Scale of Intelligence
Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
次要结局
未报告次要终点
