The effect of ventilation tubes on language development in infants with otitis media with effusion: A randomized trial

Objective. To study the effectiveness of ventilation tubes on the language development in infants with persistent otitis media with effusion (OME). Al l existing studies addressed children 3 years of age or older. Currently, O ME is detected and treated with ventilation tubes at a younger age. Because of the critical relationship between age, hearing, and language developmen t, we conducted a study of the effects of ventilation tubes on language dev elopment in infants 1 to 2 years old with persistent OME. Design. A multicenter, randomized, controlled trial (embedded in a cohort) with 2 treatment arms: 1) treatment with ventilation tubes (VT group; n = 9 3); or 2) with a period of watchful waiting (WW group; n = 94). Hearing los s and expressive and comprehensive language were assessed every 6 months, w hile tympanometry and otoscopy were performed every 3 months. Other factors with potential influence on language development were also included: adeno idectomy, hospital, attending day care, sex, age at randomization, educatio nal level of the mother, upper respiratory infections, and the native count ry of the parents and older siblings. The trial was designed to allow for t he detection of a mean difference in language development of 3 months or mo re between children allocated to the VT and WW groups. Results. No relevant differences were found in expressive or comprehensive language between the 2 groups after adjustment for educational level of the mother, IQ of the child, and differences at baseline. A principal component analysis showed that in the VT group, the children wi th frequent complaints improved 1.6 months more in comprehensive language t han those with no or some complaints. The children with favorable language stimulation, however, did not improve more than the children with less favo rable stimulation. No differences were found for expressive language among the various clusters. The probability to improve >3 months in comprehensive language was .48 (95% confidence interval [CI]:.29-.68) for children with highly educated mother s versus .09 (95% CI: .02-.30) for children whose mothers had a low educati onal level. In the WW group, these changes were .30 (95% CI: .14-.53) and . 14 (95% CI: .04-.35), respectively. The probability to improve >4 months in expressive language was .52 (95% CI: .32-.71) for children with highly edu cated mothers versus .06 (95% CI: .01-.31) for children whose mothers had a low educational level. In the WW group these changes were .42 (95% CI: .23 -.64) and .11 (95% CI: .03-.35), respectively. In addition, there were dela ys in expressive language in both groups compared with their age expected v alues. The comprehensive language of the children who were effusion-free during th e follow-up (n = 54) improved 1.5 months (95% CI: 2.2-3.2) more than that o f the children who had persistent effusion during the entire follow-up (n = 28). No differences were found for expressive language development. Disregarding the intervention contrast, improvements in hearing seemed to b e related to improvements in language development, especially in verbal com prehension. Discussion. In this study, we used the Reynell, Schlichting, and Lexi tests to study the relation between early persistent OME and language developmen t. These tests are directly related to normal language, widely accepted, an d validated. It cannot be ruled out that more specific measures such as aud itory perception tests would have produced more differences between groups, but the focus was on general language development. A total of 10 children in the WW group received treatment with ventilation tubes during follow-up. A further 11 children dropped out during the trial. A sensitivity analysis with the 10 children who received ventilation tubes did not change the results, and baseline differences were not found betwee n the 11 children who dropped out and those who completed the trial. Conclusions. In the total group of infants with persistent OME, ventilation tubes did not have any incremental effect on language development. Benefic ial effect of treatment in individual patients or subgroups of patients can , however, not be excluded.