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  • Prompt insertion of tympanostomy tubes in infants and toddlers with persistent middle ear effusion did not improve developmental outcomes at 9–11 years of age

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Therapeutics
Prompt insertion of tympanostomy tubes in infants and toddlers with persistent middle ear effusion did not improve developmental outcomes at 9–11 years of age

https://doi.org/10.1136/ebm.12.3.80

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    Paradise JL, Feldman HM, Campbell TF, et al. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med 2007;356:248–61.
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 Q In infants and toddlers with persistent middle ear effusion, is prompt insertion of tympanostomy tubes (ITTs) more effective than delayed ITTs for developmental outcomes at 9–11 years of age?

    Clinical impact ratings GP/FP/Primary care ★★★★★★☆ Paediatrics ★★★★★★☆ Surgery—ear nose throat ★★★★★★☆

    METHODS

    Embedded ImageDesign:

    randomised controlled trial.

    Embedded ImageAllocation:

    {concealed*}†.

    Embedded ImageBlinding:

    blinded (outcome assessors, data analysts, and {data collectors}†).*

    Embedded ImageFollow up period:

    up to 11 years.

    Embedded ImageSetting:

    2 hospitals and 6 paediatric group practices in or near Pittsburgh, USA.

    Embedded ImagePatients:

    429 children (about 58% boys) who were 2 months to 3 years of age and met 1 of the following criteria: persistent bilateral middle ear effusion for 90 days, persistent unilateral effusion for 135 days, or intermittent effusion for specified proportions of longer periods (eg, …

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    Footnotes

    • ↵* See glossary.

    • ↵† Information provided by author.

    • For correspondence: Dr J L Paradise, Children’s Hospital of Pittsburgh, Pittsburgh, PA, USA. jpar{at}pitt.edu

    • Sources of funding: National Institute of Child Health and Human Development; Agency for Healthcare Research and Quality; University of Pittsburgh Competitive Medical Research Fund; Children’s Hospital of Pittsburgh Research Advisory Committee; GlaxosmithKline; Pfizer.