This study will evaluate in young children the effectiveness of new therapies for acute otitis media (AOM) which, when used in addition to standard antibiotic therapy, may help to control the actions of substances within the middle ear which appear to prolong middle ear disease. Antihistamines and corticosteriods, used separately or together in addition to antibiotic drugs, will be tested in two groups of children with acute otitis media of bacterial and/or viral origin. A group of 72 infants enrolled at the beginning of their first episode of AOM will be evaluated for organisims and substances in their middle ear fluids prior to and 5 days after drug treatment; a larger group of 200 children with histories of recurrent otitis media will be treated with the drugs and evaluated over a six month period for treatment outcome, duration of fluid in the ear, and recurrence of disease. This study should clarify the potential benefits and mechanisms of action of antihistamines and corticosteriods in the treatment of AOM, and may establish their usefulness in the prevention of recurrent or prolonged ear disease in young children. To date we have not completed enrollment of the children, therefore data have not been analyzed. Identification of improved therapies for otitis media is a very high priority because nearly all young children experience this disease, and some suffer from multiple or prolonged episodes of illness which require expensive and invasive treatment, disrupt family life, and may interfere with normal development of language and cognitive skills.
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