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  • No difference existed in developmental outcomes at 3 years of age between early or delayed tympanostomy for otitis media

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Therapeutics
No difference existed in developmental outcomes at 3 years of age between early or delayed tympanostomy for otitis media

https://doi.org/10.1136/ebm.6.6.170

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    (2001) N Engl J Med 344, 1179. 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.. Apr 19;. :. –87.
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 QUESTION: In young children with persistent otitis media with effusion (OME), does prompt insertion of tympanostomy tubes protect against or minimise subsequent developmental impairment at 3 years more than delayed insertion?

    Design

    Randomised (allocation concealed*), blinded (outcome assessors),* controlled trial with follow up to 3 years of age.

    Setting

    2 hospitals and 6 private paediatric group practices in and around Pittsburgh, Pennsylvania, USA.

    Patients

    Of 6350 children enrolled by 2 months of age, 429 children (mean age 15 mo, 57% boys) in whom persistent OME developed by 3 years of age participated. Exclusion criteria included birth weight < 2270 g, small size for gestational age, history of neonatal asphyxia or other serious illness, major congenital malformation, and multiple births. 94% completed the study.

    Intervention

    216 children were allocated to early …

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    Footnotes

    • Sources of funding: National Institute for Child Health and Human Development; Agency for Healthcare Research and Quality; SmithKline Beecham Laboratories; Pfizer.

    • For correspondence: Dr J L Paradise, Children's Hospital of Pittsburgh, 3705 Fifth Avenue, Pittsburgh, PA 15213-2538, USA. Fax +1 412 692 8012.

    • A modified version of this abstract also appears in Evidence-Based Nursing.

    • ↵* See glossary.