Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management
      will meaningfully improve children's acute otitis media (AOM) experience over the succeeding
      2 years.
    

Detailed description: 
      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 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.
    

Intervention name(s): Tympanostomy tube placement; Amoxicillin-Clavulanate and/or Ceftriaxone; Ofloxacin Otic
Intervention type(s): Device; Drug; Drug
Intervention description(s): As per routine care, tympanostomy tubes will be inserted under general anesthesia, using a small radial incision in the anteroinferior portion of the tympanic membrane; a Teflon® Armstrong-type tympanostomy tube will be used.; Children randomized to nonsurgical management will receive stepwise therapy with amoxicillin-clavulanate (90/6.4 mg/kg in two divided doses for 10 days), and in the event of inadequate response, ceftriaxone (75 mg/kg intramuscularly, repeated in 48 hours), as recommended in the American Academy of Pediatrics guidelines.; Participants randomized to receive tympanostomy tubes will also be followed overtime for recurrences of AOM and treated with topical ofloxacin (Floxin® 0.3%, 5 mL) 5 drops into the affected ear twice daily for 10 days. Persistence of otorrhea after 7 days of treatment will be considered inadequate response, and children so affected will be prescribed empiric amoxicillin-clavulanate (90/6.4 mg/kg/day in two divided doses) followed by culture-directed therapy 48 hours later.
Intervention MeSH terms: Amoxicillin; Ceftriaxone; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination; Ofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ear infection; antibiotics; infants; children; pediatrics; tympanostomy tubes