- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00365092
Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11
Early Otitis and Literacy and Attention at 9 to 11 Years
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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All measures at 9 to 11 years of age:
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Woodcock Reading Mastery Tests-Revised-Normative Update
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Number of words in a grade-level passage read correctly in one minute
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Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
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Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery
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Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing
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Children's version of the Hearing in Noise Test
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Disruptive Behavior Disorders Rating Scale
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Child Behavior Checklist, parent report
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Child Behavior Checklist, teacher report
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Impairment Rating Scales, parent report
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Impairment Rating Scales, teacher report
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Computerized visual continuous performance test
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Computerized auditory continuous performance test
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Wechsler Abbreviated Scale of Intelligence
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Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
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Collaborators and Investigators
Investigators
- Principal Investigator: Jack L Paradise, MD, University of Pittsburgh
Publications and helpful links
General Publications
- Paradise JL, Campbell TF, Dollaghan CA, Feldman HM, Bernard BS, Colborn DK, Rockette HE, Janosky JE, Pitcairn DL, Kurs-Lasky M, Sabo DL, Smith CG. Developmental outcomes after early or delayed insertion of tympanostomy tubes. N Engl J Med. 2005 Aug 11;353(6):576-86. doi: 10.1056/NEJMoa050406.
- Paradise JL, Dollaghan CA, Campbell TF, Feldman HM, Bernard BS, Colborn DK, Rockette HE, Janosky JE, Pitcairn DL, Kurs-Lasky M, Sabo DL, Smith CG. Otitis media and tympanostomy tube insertion during the first three years of life: developmental outcomes at the age of four years. Pediatrics. 2003 Aug;112(2):265-77. doi: 10.1542/peds.112.2.265.
- Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Colborn DK, Bernard BS, Rockette HE, Janosky JE, Pitcairn DL, Sabo DL, Kurs-Lasky M, Smith CG. Early versus delayed insertion of tympanostomy tubes for persistent otitis media: developmental outcomes at the age of three years in relation to prerandomization illness patterns and hearing levels. Pediatr Infect Dis J. 2003 Apr;22(4):309-14. doi: 10.1097/01.inf.0000059764.77704.55.
- Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Colborn DK, Bernard BS, Rockette HE, Janosky JE, Pitcairn DL, Sabo DL, Kurs-Lasky M, Smith CG. Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years. N Engl J Med. 2001 Apr 19;344(16):1179-87. doi: 10.1056/NEJM200104193441601.
- Paradise JL, Feldman HM, Campbell TF, Dollaghan CA, Rockette HE, Pitcairn DL, Smith CG, Colborn DK, Bernard BS, Kurs-Lasky M, Janosky JE, Sabo DL, O'Connor RE, Pelham WE Jr. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med. 2007 Jan 18;356(3):248-61. doi: 10.1056/NEJMoa062980.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD042080 (NIH)
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