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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?
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 and around Pittsburgh, Pennsylvania, USA.
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.
216 children were allocated to early …
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.