Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Otitis and Literacy and Attention at 9 to 11 Years

Conditions
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Otitis Media, Middle Ear Effusion

Intervention / Treatment
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* Procedure: Insertion of tympanostomy tubes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, less than 62 days of age at enrollment Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 61 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Insertion of tympanostomy tubes|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insertion of tympanostomy tubes, Otitis media with effusion, Child development, Literacy, Attention, Middle-ear effusion, Educational status, Behavior, Social behavior, Achievement