Persistent middle ear effusion in infancy and early childhood has been blamed for impairments of speech, language, cognition and psychosocial development later in life. Whether that blame is justified remains unresolved and a matter of controversy, because studies of the relationships involved have been limited and often contradictory and because none was designed so as to address the issue of causality. At issue in particular is the common practice of subjecting infants and young children with persistent otitis media with effusion (OME) to tympanostomy tube placement specifically to reduce the risk of developmental impairment. Currently children younger than age 3 years undergo an estimated 313 000 tympanostomy tube placement operations per year, at a cost of about $750 million.
If a causal association between early life OME and later developmental impairment were to be established, answers would also be needed to the questions whether the adverse effects of OME are linear or threshold, whether they are permanent or transient and whether they are preventable by timely tube placement.
A prospective study designed to address all of these questions is currently under way at Children's Hospital of Pittsburgh. The study involves enrolling a large, demographically diverse sample of normal infants before 2 months of age; monitoring them for the presence or absence of otitis media throughout the first 3 years of life; identifying those in whom OME has persisted for specified minimum periods; randomly assigning those subjects either to prompt tube placement or to delayed tube placement if OME persists; and administering a battery of standardized developmental tests to those subjects and to a sample of the others at ages 3, 4 and 6 years. Details of the study design and procedures are described in this report.