It is unknown whether persistent early-life otitis media results in lasting impairment of children’s development and whether the insertion of tympanostomy tubes prevents or lessens such impairment. Paradise and colleagues performed a randomized clinical trial that assigned children who met specified criteria of middle-ear effusion in their first three years of life to undergo either prompt or delayed tympanostomy tube insertion.

In the associational component of the trial, the authors studied representative samples of the remaining study population to determine associations between cumulative duration of middle-ear effusion in the first three years of life and developmental outcomes identical to those studied in the randomized group at similar ages.

A total of 429 children underwent randomization, with 402 (93.7 percent) receiving developmental testing at three years of age. Despite large differences in cumulative duration of middle-ear effusion exposure, there were no significant developmental differences between the early and delayed tympanostomy tube insertion groups. In the associational group of 241 children, there were no significant associations between antecedent time with middle-ear effusion and the children’s scores on aspects of cognition, spontaneous expressive language, and speech sound production. Researchers obtained developmental findings at the age of four years in 397 children (92.5 percent) in the randomized trial and in 234 children (97.1 percent) in the associational sample.

The investigators used pneumatic otoscopy, supplemented in most cases by tympanometry, to assess the status of the children’s middle ear at least monthly until they were three years of age. Children who developed substantial and persistent middle-ear effusion lasting 90 to 135 days despite antibiotic treatment were eligible for randomization. Development testing was conducted as soon as possible after their fourth birthday via formal tests, samples of conversation, and parent-reported inventories of parent-child stress and child behavior.

The only significant difference between the two groups was a modest but statistically significant difference in scores on the Nonword Repetition Test. There were no significant differences between the two groups with regard to parent-child stress or child behavior. Mean scores on all outcome measures were generally most favorable among the most socioeconomically advantaged children.

In the associational sample, correlations between individual children’s scores at four years of age and the cumulative proportions of days with middle-ear effusion in the first three years of life were generally weak and, in most cases, nonsignificant. After adjustment for socioeconomic variables (gender, race, maternal education, health insurance status, and study site grouping) and for hearing thresholds, the only scores that correlated with duration of middle-ear effusion in the first three years of life were those on the McCarthy Verbal subscale and the two measures of parent-child stress.

The study’s findings in children at four years of age reinforce findings from an earlier stage of this study. In the randomized group, the authors found no statistically significant differences in scores at age four in the early-treatment group compared with the delayed-treatment groups on a variety of developmental outcome measures. In children in the associational component, some weak correlations were found between cumulative days of middle-ear effusion and performance on those measures. In both components, socio-demographic variables appeared to be the most important factors influencing developmental outcomes.

Based on findings in these children at three and four years of age, the authors conclude that persistent otitis media in the first three years of life does not have an adverse effect on the children’s development. They recommend using restraint in recommending tympanostomy tube insertion in these children.