Child Development in Relation to Early Otitis Media

Janine E. Janosky, Ph.D. - Co-Investigator

The main objectives of this study are to determine whether persistent otitis media with effusion (OME) during the first 3 years of life results in lasting impairments of speech, language, cognitive, or psychosocial development, and if so, whether prompt tympanostomy-tube placement (TTP) is efficacious in preventing or lessening the impairments. Secondary objectives are (a) to determine whether and to what extent the number of TTP operations can be reduced by increasing the duration of OME required before TTP is undertaken, and to delineate the resulting long-term otologic and audiologic consequences, if any; and (b) to delineate more precisely than heretofore, and with less distortion from surgical intervention, the occurrence and natural history of otitis media (OM) and associated hearing loss in infants and young children.

A total of 5338 healthy neonates from 7 Pittsburgh-area pediatric practices and the Children's Hospital Continuity Clinic will be enrolled over a 21-month period. Middle-ear status will be monitored at frequent intervals by means of tympanometry and pneumatic otoscopy. Hearing levels will be monitored monthly in children who develop persistent OME. Children who meet specific criteria concerning persistent OME during the first 3 years of life will, subject to consent, be randomly assigned to receive TTP either promptly ("early-TTP"), or after a defined extended period if OME is still present ("late-TTP"). Most in the early-TTP group may be expected to achieve prompt and sustained resolution of OME, whereas many in the late-TTP group will continue to have OME until later spontaneous resolution or eventual TTP. A uniform protocol for treatment of types of OM other than persistent OME will be used for all subjects. After age 3 years, TTP criteria will be made the same for all subjects.

Developmental functioning will be assessed at ages 2 mos. and 1 and 2 yrs. through standardized questionnaires. Speech, language, cognitive, and psychosocial development will be assessed in all randomized subjects, and in a random sample of subjects who have not met TTP criteria, at ages 3,4,5,6, and 7 yrs., by blinded observers using standardized tests. Otologic and audiologic status will be monitored systematically.

Analyses of developmental outcomes in the early-TTP and late-TTP groups, and in non-TTP subjects, supplemented by analyses of otological and audiological outcomes, should enable physicians to better judge the advisability and optimal timing of TTP.