Delayed insertion of ear tubes doesn't impair children

Journal of Family Practice, April, 2007

* Clinical question

Does delayed insertion of tympanostomy tubes impair long-term outcomes for children with persistent middle-ear effusion?

* Bottom line

No, delayed tympanostomy tube insertion does not result in any developmental or other impairment. In fact, the delay helps many children avoid tubes altogether.

Level of evidence

1b: Individual randomized controlled trials (with narrow confidence interval)

Study design

Randomized controlled trial (single-blinded)

Funding

Government

Allocation

Concealed

Setting

Outpatient (any)

Synopsis

Many parents and clinicians believe that there is a significant risk of permanent harm if tympanostomy tubes are not promptly inserted for children with persistent middle-ear effusion.

In this study--a follow-up to an earlier study (N Engl J Med 2005; 353:576; discussed in the POEM "Early tymp tubes do not improve outcomes after 3 years," J Fam Pract 2005; 54:929)--429 children between the ages of 2 months and 3 years with middle-ear effusion for at least 90 days (bilateral) or 135 days (unilateral) were randomized to receive either prompt or delayed tympanostomy tube insertion. The delay was 6 months for bilateral effusion and 9 months for unilateral effusion.

Allocation was concealed, groups were balanced at the start of the study, and analysis was by intention-to-treat.

One hundred ninety-five of 216 in the early-treatment group and 196 of 213 in the delayed-treatment group underwent developmental testing between the ages of 9 and 11 years. At the time of this final evaluation, 86% in the early treatment group had received tympanostomy tubes compared with only 49% in the delayed treatment group.

There was no differences between groups in the results of a broad range of tests, including evaluation of hearing, reading, oral fluency, auditory processing, phonological processing, behavior, or intelligence.

There was also no difference between these groups and a group of children with ear problems that weren't bad enough to qualify them for the study.

FAST TRACK

There was no difference in hearing or oral fluency between children in the early vs delayed treatment groups

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; 356:248-261.