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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
  1. Morten Lindbaek, MD
  1. University of Oslo,
 Oslo, Norway

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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 ★★★★★★☆


    Embedded ImageDesign:

    randomised controlled trial.

    Embedded ImageAllocation:


    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, intermittent bilateral effusion ⩾121 days during a 180 day period, or intermittent unilateral effusion ⩾181 days during a 270 day period).

    Embedded ImageIntervention:

    prompt ITTs (n = 216) or delayed ITTs if effusion persisted (6 mo for bilateral effusion or 9 mo for unilateral effusion) (n = 213).

    Embedded ImageOutcomes:

    48 developmental measures (see

    Embedded ImagePatient follow up:

    91% (intention to treat analysis).


    At the time of testing, 84% of children in the prompt treatment group and 45% of children in the delayed treatment group had undergone tube insertion. Groups did not differ for the 48 developmental measures except for Total Problems score by parent’s rating, which favoured the delayed treatment group (mean score difference 2 points, 95% CI 0.1 to 4.8). See table at


    In infants and toddlers with persistent middle ear effusion, prompt insertion of tympanostomy tubes was not more effective than delayed insertion for developmental outcomes at 9–11 years.


    The study by Paradise et al has made an important contribution to the understanding of the developmental consequences of otitis media with effusion. This study is the latest evidence to show that a conservative wait-and-see approach will give the best outcome in children ⩽3 years of age, avoiding unnecessary operations. Although some small differences were found, none of them can be considered clinically significant and all of them favoured the delayed treatment group. Berman stated that this study is the end of an otitis research era.1

    The study has some important limitations. 45% of children in the control group received ITTs compared with 84% in the intervention group. This is explained by the fact that in the delayed treatment group, only patients whose effusion failed to clear spontaneously were provided with ITTs. Accordingly, the spontaneous recovery rate of effusion was considerable. The 2 possible confounders—use of antibiotics and rates of (adeno)tonsillectomies in each group—seem to be ruled out because {the criteria for antiobiotic use were equal for both groups and the number of (adeno)tonsillectomy rates low and equal among the groups}*.

    How will these findings affect my practice? I will continue to follow up my otitis prone children carefully and liberally refer them to ear, nose, and throat specialists. The new American guidelines,2 based in part on the Paradise studies, state that ITTs are indicated if a persistent hearing loss of 40 dB is found, a speech or language delay is diagnosed, or a structural abnormality of the ear drum is found. More emphasis on measuring hearing loss in these children remains to be a challenge, especially in children under 4 years. Children with persistent middle ear effusion should be referred to audiologists to measure possible hearing loss before considering ITTs.

    *Information provided by author.


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    • * See glossary.

    • Information provided by author.

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

    • 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.