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Completed

NCT Number: NCT00365092

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

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.

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Key information

Conditions

Otitis Media Behavior Communication Ear Diseases Literacy Middle Ear Effusion Otitis Otitis Media with Effusion Otorhinolaryngologic Diseases Social Behavior

Age range

0 year–61 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insertion of tympanostomy tubes

Procedure

Primary outcomes

  1. All measures at 9 to 11 years of age:

  2. Woodcock Reading Mastery Tests-Revised-Normative Update

  3. Number of words in a grade-level passage read correctly in one minute

  4. Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery

  5. Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery

  6. Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing

  7. Children's version of the Hearing in Noise Test

  8. Disruptive Behavior Disorders Rating Scale

  9. Child Behavior Checklist, parent report

  10. Child Behavior Checklist, teacher report

  11. Impairment Rating Scales, parent report

  12. Impairment Rating Scales, teacher report

  13. Computerized visual continuous performance test

  14. Computerized auditory continuous performance test

  15. Wechsler Abbreviated Scale of Intelligence

  16. Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Registry information

Official study title

Early Otitis and Literacy and Attention at 9 to 11 Years

Important dates

Study start
2002
Study completion
2005
First posted
Aug 17, 2006
Registry last updated
Aug 17, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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