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

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00365092
First received: August 15, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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 Intervention
Otitis Media
Middle Ear Effusion
Procedure: Insertion of tympanostomy tubes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Early Otitis and Literacy and Attention at 9 to 11 Years

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Estimated Enrollment: 400
Study Start Date: April 2002
Estimated Study Completion Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   up to 61 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365092

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Investigators
Principal Investigator: Jack L Paradise, MD Children's Hospital of Pittsburgh
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00365092     History of Changes
Other Study ID Numbers: R01HD42080
Study First Received: August 15, 2006
Last Updated: August 15, 2006
Health Authority: United States: Federal Government

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
Literacy
Attention
Middle-ear effusion
Educational status
Behavior
Social behavior
Achievement

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

ClinicalTrials.gov processed this record on July 28, 2014