Posterior vs. Anterior Tympanostomy Tube Placement
The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. However, tubes can also be placed in another section, called the posterior-inferior quadrant. Ear tubes usually fall out of the ear drum on their own. In most patients, the hole in the ear drum where the tube used to be closes on its own. Sometimes (in about 2% of patients), the hole does not close on its own and might need surgery. We want to study ear tube placement in the posterior-inferior quadrant because surgery to repair a hole in the eardrum is easier in this location. For this study, children will receive an ear tube in the usual location (anterior-inferior quadrant) in one ear and the new location (posterior-inferior quadrant) in the other ear. Researchers will determine which ear has the new location using random assignment (like flipping a coin). Researchers will collect information about hearing tests, whether there is ear drainage (otorrhea), if the tube is blocked (occluded), and how the ear drum looks for up to 37 months after tube placement. Participants will answer study questions at 2-12 weeks and 6, 12, 18, 24, 30, and 36 months after surgery. These questions will ask about whether tubes have fallen out of the ear drum, whether there is a hole in the ear drum, whether there has been drainage from the ear or other ear symptoms, and whether there have been any visits to the doctor for ear problems. Researchers will use this information to compare ears with anterior-inferior tube placement and ears with posterior-inferior tube placement to see if there are differences in common complications following tube placement.
Conditions:
🦠 Otitis Media in Children 🦠 Chronic Otitis Media With Effusion 🦠 Recurrent Acute Otitis Media
🗓️ Study Start (Actual) 29 February 2024
🗓️ Primary Completion (Estimated) February 2028
✅ Study Completion (Estimated) February 2028
👥 Enrollment (Estimated) 386
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Pittsburgh, Pennsylvania, United States
📍 Sewickley, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Ages 6 months -14 years
    • 2. Bilateral tympanostomy tube placement
    • 3. First tympanostomy tubes placement
    • 4. Indication for tympanostomy tube placement is otitis media

    Exclusion Criteria:

    • 1. Undergoing tympanostomy tube placement for indication other than otitis media
    • 2. Receiving tubes other than Armstrong grommet.
    • 3. Genetic disorder that impacts the craniofacial structure, immune system, or mucosal secretions such as Downs syndrome, Stickler syndrome, Treacher Collins syndrome, other genetic disorder associated with craniofacial anomalies, Severe Combined Immunodeficiency disorder, Cystic Fibrosis, or Primary Ciliary Dyskinesia
    • 4. Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
    • 5. Caregivers who cannot speak, read, or write in English proficiently
    • 6. Prior or current otologic surgery other than tympanostomy tube placement
    • 7. On systemic corticosteroids at the time of enrollment
    • 8. Immunodeficiency (acquired or congenital)
    • 9. Current retraction, cholesteatoma, or middle ear mass
    • 10. Atresia
    • 11. Sensorineural hearing loss
    • 12. Known ossicular chain anomaly
Ages Eligible for Study: 6 Months to 14 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 December 2023
  • First Submitted that Met QC Criteria 3 January 2024
  • First Posted 5 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 February 2024
  • Last Update Posted 4 March 2024
  • Last Verified February 2024