© 2001 Evidence-Based Nursing
Treatment
Developmental outcomes did not differ for early or delayed tympanostomy tube insertion in young children with otitis media
Paradise JL, Feldman HM, Campbell TF, et al. 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;344:1179–87
QUESTION: In young children with persistent otitis media with effusion, does prompt insertion of tympanostomy tubes protect against or minimise subsequent developmental impairment at 3 years of age compared with delayed insertion?
Randomised (allocation concealed), blinded (outcome assessors), controlled trial with follow up to 3 years of age.
2 hospitals and 6 private paediatric group practices in Pittsburgh, Pennsylvania, USA.
Of 6350 children enrolled by age 2 months, 429 children (mean age 15 mo, 57% boys) in whom persistent otitis media with effusion developed by the age of 3 years participated. Exclusion criteria included birth weight <2270 g, small for gestational age, history of neonatal asphyxia or other serious illness, major congenital malformation or chronic illness, and multiple births. 94% completed the study.
216 children were allocated to early (defined as "as soon as possible") insertion of tympanostomy tubes (grommets) and 213 were allocated to late (defined as "up to 9 mo or later if effusion persisted") insertion of tympanostomy tubes.
Developmental outcomes including speech, language, cognition, and psychosocial development (parenting stress and child behaviour) at 3 years of age.
At age
Western Australian Centre for Evidence Based Nursing and Midwifery Perth, Western Australia, Australia
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