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

Primary Purpose

Otitis Media, Middle Ear Effusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insertion of tympanostomy tubes
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media focused on measuring Insertion of tympanostomy tubes, Otitis media with effusion, Child development, Literacy, Attention, Middle-ear effusion, Educational status, Behavior, Social behavior, Achievement

Eligibility Criteria

0 Years - 61 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Hospital of Pittsburgh

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 15, 2006
Last Updated
August 15, 2006
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00365092
Brief Title
Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11
Official Title
Early Otitis and Literacy and Attention at 9 to 11 Years
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media, Middle Ear Effusion
Keywords
Insertion of tympanostomy tubes, Otitis media with effusion, Child development, Literacy, Attention, Middle-ear effusion, Educational status, Behavior, Social behavior, Achievement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Insertion of tympanostomy tubes
Primary Outcome Measure Information:
Title
All measures at 9 to 11 years of age:
Title
Woodcock Reading Mastery Tests-Revised-Normative Update
Title
Number of words in a grade-level passage read correctly in one minute
Title
Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
Title
Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery
Title
Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing
Title
Children's version of the Hearing in Noise Test
Title
Disruptive Behavior Disorders Rating Scale
Title
Child Behavior Checklist, parent report
Title
Child Behavior Checklist, teacher report
Title
Impairment Rating Scales, parent report
Title
Impairment Rating Scales, teacher report
Title
Computerized visual continuous performance test
Title
Computerized auditory continuous performance test
Title
Wechsler Abbreviated Scale of Intelligence
Title
Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
61 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack L Paradise, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16093466
Citation
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.
Results Reference
background
PubMed Identifier
12897272
Citation
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.
Results Reference
background
PubMed Identifier
12690269
Citation
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.
Results Reference
background
PubMed Identifier
11309632
Citation
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.
Results Reference
background
PubMed Identifier
17229952
Citation
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.
Results Reference
derived

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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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