Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

• Status: Completed
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alejandro Hoberman
• Collaborators: George Washington University; National Institute on Deafness and Other Communication Disorders (NIDCD)
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ceftriaxone; Clavulanic Acid; Clavulanic Acids; Ofloxacin

Criteria

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.