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Early Insertion of Tympanostomy Tubes Does Not Improve Developmental Outcome In Children


  • In children less than three years of age with OME, should tympanostomy tubes be placed to result in better developmental outcome?

Clinical Bottom Lines

  1. Children younger than three years of age who have persistent otitis media, should not have prompt insertion of tympanostomy tubes with the intention to improve developmental outcomes at the age of three years.
  2. Hearing tests should be performed in children with middle-ear effusion.
  3. Children in the late treatment group were three times as likely to have effusion more than 50% of the time during the first 12 months after randomization and twice as likely to have persistent effusion during the first 24 months.

Summary of Key Evidence

  1. 6350 healthy infants were enrolled and followed prospectively. Children with persistent effusion were randomized to receive tubes either as soon as possible or 9 months later if effusion persisted.1
  2. Of 588 patients who met the eligibility criteria for the study, 429 (73%) underwent randomization. Therefore, 27% declined.
  3. 402 of the 429 children (94%) received developmental testing.
  4. Exclusion criteria: BW <2270g (5 lb.), SGA, h/o neonatal asphyxia or serious illness, major congenital malformation or chronic illness, a multiple, a sibling in study, in foster care or adopted, deceased or ill or substance abusing mother, mother <18 years, English not primary language.
  5. All children had audiometric testing.
  6. By the age of three years, there were no significant difference between the language, cognition, and psychosocial development of children who had tubes inserted early or late.

Additional Comments

  • Current guidelines support insertion of tympanostomy tubes for otitis media with effusion for greater than three months.
  • There is no data on treatment for acute otitis media and assessment of antimicrobial use.
  • There is data on all developmental tests that were done: developmental outcomes of cognition, receptive and expressive speech, speech-sound production, and behavior.
  • This study does not address the issue of recurrent otitis media.


  1. Paradise JL, Feldman HM, Campbell TF, et al. Effect of early or delayed insertion of tympanostomy tubes for persistent otits media on developmental outcomes at the age of three years. N Engl J Med 2001;344:1179-1187.
  2. Paradise JL, Feldman HM, Colborn K, et al. Parental stress and parent-rated child behavior in relation to otitis media in their first three years of life. Pediatrics 1999;104:1264-1273.
  3. Paradise JL, Dollaghan CA, Campbell TF, et al. Language and speech sound production, and cognition in 3-year old children in relation to otitis media in their first three years of life. Pediatrics 2000;105:1119-1130.
  4. Linsk R, Gilsdorf J, and Lesperance M. When amoxicillin fails. Contemporary Pediatrics 2001; 16:67-88..

CAT Author: Sandra H. Jee, MD

CAT Appraisers: Jonathan Fliegel, MD

Date appraised: May 16, 2001

Last updated March 23, 2003
Department of Pediatrics and Communicable Diseases
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