Early insertion of tympanostomy tubes during the first 3 years of life did not significantly improve the majority of developmental outcomes at age 6, compared with later insertion, in children with persistent otitis media with effusion, said Jack L. Paradise, M.D., of the University of Pittsburgh, and his colleagues.
In a randomized clinical trial of children with persistent effusion who were 61 days to 3 years old, 201 children received tubes promptly (early-treatment group) and 194 received tubes 6 months later in cases of persistent bilateral effusion and 9 months later for unilateral effusion (delayed-treatment group). The children were enrolled in the study as healthy infants aged 2–61 days, and their middle-ear status was monitored regularly from the time of their enrollment.
Abnormal hearing was diagnosed while effusion was present in approximately 75% of those with bilateral effusion and in approximately 50% of the children with unilateral effusion prior to the insertion of tubes (N. Engl. J. Med. 2005;353:576–86).
At 6 years, unilateral effusion was present in 15 children (7%) in the early-treatment group and 20 children (10%) in the delayed-treatment group, and bilateral effusion was present in 7 children (3%) in the early-treatment group and 3 children (2%) in the delayed-treatment group.
There were no significant differences in the mean scores between the early- and delayed-treatment groups on most assessment tests at 6 years, including the Wechsler Intelligence Scale for Children (scores of 98 for both groups) and the Percentage of Consonants Correct-Revised test (scores of 96 for both groups).
The only significant difference in outcome at 6 years was a higher mean score on the Nonword Repetition Task in the early-treatment group, compared with the delayed-treatment group (76 vs. 74).
These data support and extend results from a previous study by Dr. Paradise and his colleagues in which early insertion of tubes did not improve developmental outcomes at ages 3 or 4 years.