title: 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.
abstract: BACKGROUND
  Whether prompt insertion of tympanostomy tubes in children with persistent early life otitis media prevents or minimizes subsequent developmental impairment has been the subject of conflicting opinions and differing approaches to management.
  
  
  METHODS
  We randomly assigned 429 children with persistent middle ear effusion (MEE) before the age of 3 years to have tympanostomy tubes inserted either as soon as possible or up to 9 months later if MEE persisted. In 402 of these children, we found no significant differences at age 3 years between the 2 treatment groups in mean scores on any measure of speech, language and cognition and in 401 of the children no significant differences in measures of psychosocial development. We then examined outcomes within subgroups of children who might have been the most severely affected, namely those who had been randomized on the basis of bilateral, continuous MEE rather than unilateral and/or discontinuous MEE and those who had the greatest degrees of hearing loss.
  
  
  RESULTS
  In none of the subgroups we considered were scores on any outcome measure significantly more favorable in children in the early treatment group than in children in the late treatment group.
  
  
  CONCLUSIONS
  In otherwise normal children who have MEE, during the first 3 years of life within the durations we studied, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at age 3 years, irrespective of whether MEE has been continuous or discontinuous and unilateral or bilateral and whether or not MEE has been accompanied by mild to moderate hearing loss.
authors.affiliation: Department of Pediatrics, Children's Hospital of Pittsburgh, 3705 Fifth Avenue, Pittsburgh, PA 15213-2538, USA. jpar@pitt.edu
authors.forename: Jack L
authors.initials: JL
authors.lastname: Paradise
authors.forename: Heidi M
authors.initials: HM
authors.lastname: Feldman
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Campbell
authors.forename: Christine A
authors.initials: CA
authors.lastname: Dollaghan
authors.forename: D Kathleen
authors.initials: DK
authors.lastname: Colborn
authors.forename: Beverly S
authors.initials: BS
authors.lastname: Bernard
authors.forename: Howard E
authors.initials: HE
authors.lastname: Rockette
authors.forename: Janine E
authors.initials: JE
authors.lastname: Janosky
authors.forename: Dayna L
authors.initials: DL
authors.lastname: Pitcairn
authors.forename: Diane L
authors.initials: DL
authors.lastname: Sabo
authors.forename: Marcia
authors.initials: M
authors.lastname: Kurs-Lasky
authors.forename: Clyde G
authors.initials: CG
authors.lastname: Smith
mesh_terms: D000158:Acoustic Impedance Tests; D000367:Age Factors; D001309:Auditory Threshold; D002648:Child; D002657:Child Development / Q000502:physiology*; D002675:Child, Preschool; D002908:Chronic Disease; D005260:Female; D006311:Hearing Disorders / Q000453:epidemiology / Q000209:etiology*; D006320:Hearing Tests; D006801:Humans; D007223:Infant; D007804:Language Development; D008876:Middle Ear Ventilation / Q000009:adverse effects / Q000379:methods*; D010034:Otitis Media with Effusion / Q000175:diagnosis / Q000601:surgery*; D011183:Postoperative Complications; D011336:Probability; D011379:Prognosis; D012016:Reference Values; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index