CompletedNot Applicable

Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media

United States250 participantsStarted 2015-11

Plain-language 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.

Who can participate

Age range6 Months – 35 Months

SexALL

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Inclusion criteria

✓. are aged 6-35 months,
✓. 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
✓. 2 of these AOM episodes have been documented by trained study personnel.

Exclusion criteria

✕. have a history of TTP,
✕. 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),
✕. are allergic to amoxicillin,
✕. have a congenital anomaly that might increase the risk of recurrences (e.g., cleft palate, Down's syndrome),
✕. have had otitis media effusion for at least 3 months in addition to rAOM, or
✕. have sensorineural hearing loss.

What they're measuring

The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year

Timeframe: Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years. For each child with incomplete 2-year follow-up, multiple imputation was used and values for the remaining days/years were imputed.

Trial details

NCT IDNCT02567825

SponsorAlejandro Hoberman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03

Results submitted2021-09-29

View on ClinicalTrials.gov More Acute Otitis Media trials