BACKGROUND: Fluid in the middle ear creates a conductive hearing loss. This has historically raised concern for potential delays in child development. Persistent otitis media with effusion (OME) is, therefore, the primary indication for tympanostomy tube placement. This study re-examines the link between middle ear effusions, developmental outcomes, and the ability of this surgical intervention to affect these outcomes.
POPULATION STUDIED: Healthy newborns were recruited to participate from a variety of practice settings in the greater Pittsburgh area. Exclusion criteria included: birth weight less than 2270 g, congenital malformation or significant neonatal illness, multiple birth, maternal illness, maternal drug abuse, and several social limitations (foster care, inability to give informed consent, younger than 18 years, English as a second language).
STUDY DESIGN AND VALIDITY: This was a nonblinded randomized clinical trial. Of 6350 patients screened between the ages of 2 days and 2 months, 588 met eligibility criteria, and 429 ultimately participated. The subjects were examined monthly to assess for the presence of OME from age 2 months until 3 years. Children with significant effusions (defined either as bilateral effusions persisting 90 or more days or unilateral effusions persisting for more than 135 days) were randomized to an early intervention group (n=216) or a delayed treatment group (n=213). Children in the early treatment group received tympanostomy tubes as soon as possible. Children in the delayed treatment group had tubes placed either 6 months (for persistent bilateral OME) or 9 months (for persistent unilateral OME) after the initial diagnosis. Ninety-four percent of the subjects (402 of 429) successfully completed developmental testing at the age of 3 years. One of the particular strengths of this study is its methodologic attention to detail. The study groups are well defined and well described, and relevant outcomes are reported. Questions that were not adequately addressed, however, include: (1) Is 3 years an adequate length for follow-up in terms of reliable developmental outcomes?1 and (2) Could tympanostomy tube placement be delayed even longer than 9 months (or perhaps avoided completely)?
OUTCOMES MEASURED: Three sets of primary developmental outcomes were measured up to 3 years after randomization: formal norm-referenced tests to assess cognition and receptive language skills, conversational sampling to assess expressive language skills, and parental questionnaires to assess parental distress and child behavior.
RESULTS: By age 3 years, 82% of the early intervention group (n=169) and 34% of the delayed treatment group (n=66) had undergone tympanostomy tube placement. There were no significant differences between groups for receptive or expressive language skills, cognition, parental distress, or child behaviors.
This study provides compelling evidence that placement of tympanostomy tubes at the time of diagnosis in otherwise healthy children with persistent OME is no more effective than withholding treatment for up to 9 months. In this setting, early surgical intervention has no effect on cognitive development, language acquisition and development, or behavior.