Clinical Question: Does delayed insertion of tympanostomy tubes impair long-term outcomes for children with persistent middle-ear effusion?
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)
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.
There was no difference in hearing or oral fluency between children in the early vs delayed treatment groups
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.