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

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ClinicalTrials.gov Identifier: NCT00365092
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : August 17, 2006
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
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.

Condition or disease Intervention/treatment
Otitis Media Middle Ear Effusion Procedure: Insertion of tympanostomy tubes

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Early Otitis and Literacy and Attention at 9 to 11 Years
Study Start Date : April 2002
Estimated Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Disorders
U.S. FDA Resources

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 61 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365092

United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Jack L Paradise, MD University of Pittsburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00365092     History of Changes
Other Study ID Numbers: R01HD042080 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: August 17, 2006
Last Verified: August 2006

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Insertion of tympanostomy tubes
Otitis media with effusion
Child development
Middle-ear effusion
Educational status
Social behavior

Additional relevant MeSH terms:
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases