Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

Tympanostomy tube placement (TTP) for recurrent acute otitis media (rAOM) is frequently
performed in children under 3 years of age; however, a critical need exists to establish its
risk/benefit ratio. Seventy percent of children experience at least one episode of AOM during
the first year of life; 20% of children have rAOM. The efficacy of TTP for preventing rAOM,
assumedly by maintaining middle-ear ventilation, remains unclear. Benefits of TTP must be
balanced against risks of anesthesia, complications and sequelae of surgery, and cost.
Accordingly, the objective of this proposal is to determine the efficacy of TTP in children
aged 6-35 months, the group in which rAOM is most troublesome. The central hypothesis is that
in children with rAOM, the operation will prove effective over the ensuing 2 years overall,
but the benefit in a more severely affected, and therefore higher-risk subgroup may be
substantially greater than in a less severely affected subgroup, in whom benefits may not
outweigh risks. The rationale for this research is based on a belief that the limited nature
of the benefit of TTP found in earlier clinical trials may have been the result of enrolling
children whose illnesses had not been diagnosed using stringent criteria and/or whose
ascertainment of episodes had relied on undocumented histories. The primary objective is to
determine the extent to which TTP reduces the overall rate of recurrences in children with
rAOM over a 2-year period. In a phase 3 randomized, clinical trial, children aged 6-35 months
who are at risk for rAOM will be followed prospectively and examined promptly with new
respiratory illnesses to accurately document episodes of AOM. A total of 240 children who
meet stringent inclusion criteria for rAOM will be eligible to undergo randomization within
strata (age and exposure to other children) to receive TTP or nonsurgical management.
Children will be followed for 2 years; the average number of episodes of AOM will be
documented and compared between groups. The secondary objective is to determine changes
following TTP in nasopharyngeal (NP) colonization with resistant bacteria. At the time of
randomization and 3 times a year for 2 years, NP specimens will be obtained and cultured.
Susceptibility testing and serotyping will be performed, and the proportions of children
colonized with resistant bacteria compared between treatment groups. The tertiary objective
is to determine cost-effectiveness of TTP. The investigators will calculate both direct
medical and nonmedical costs and correlate this with the number of days that each child has
AOM symptoms, otorrhea, and any adverse events or complications. The proposed research is
innovative, as the investigators will document AOM episodes prospectively using stringent
diagnostic criteria and obtain digital tympanic membrane images otoendoscopically to enhance
accuracy of observations. Findings of the proposed study will provide clinicians and parents
with dependable evidence concerning the overall effects of TTP compared with nonsurgical
management in children with rAOM of varying degrees of severity, enabling evidence-based
decisions regarding an important component of the children's healthcare.

Inclusion Criteria

1. are aged 6-35 months,

2. have rAOM, defined as the occurrence of 3 AOM episodes in 6 months or 4 episodes in 12
months with ≥1 episode in the preceding 6 months, and

3. 2 of these AOM episodes have been documented by trained study personnel.

Exclusion Criteria

1. have a history of TTP,

2. have a chronic illness (cystic fibrosis, neoplasm, juvenile diabetes, renal or hepatic
insufficiency, immune dysfunction, malabsorption, inflammatory bowel disease, severe
asthma requiring at least 4 courses of oral corticosteroids during the last 12
months),

3. are allergic to amoxicillin,

4. have a congenital anomaly that might increase the risk of recurrences (e.g., cleft
palate, Down's syndrome),

5. have had otitis media effusion for at least 3 months in addition to rAOM, or

6. have sensorineural hearing loss.