Middle Ear Disease Before Age 3, Treatment With Ear Tubes, and Literacy and Attentional Abilities at Ages 9 to 11
Condition: Otitis Media; Middle Ear Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional

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.
    

Intervention name(s): Insertion of tympanostomy tubes
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Insertion of tympanostomy tubes; Otitis media with effusion; Child development; Literacy; Attention; Middle-ear effusion; Educational status; Behavior; Social behavior; Achievement