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

Otitis Media Clinical Trial

Official title:

Early Otitis and Literacy and Attention at 9 to 11 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365092
• Other study ID #: R01HD042080
• Status: Completed
• Phase: N/A
• First received: August 15, 2006
• Last updated: August 15, 2006
• Start date: April 2002
• Est. completion date: March 2005

Study information

• Verified date: August 2006
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 61 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Middle Ear Effusion
• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Procedure:
• Insertion of tympanostomy tubes

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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