Posterior vs. Anterior Tympanostomy Tube Placement

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Otitis Media in Children, Chronic Otitis Media With Effusion, Recurrent Acute Otitis Media

In brief

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.

Key facts

Study ID

NCT06191562

Run by

David Chi, MD

People needed

386

Starts

2024-02-29

Expected to finish

2028-02-01

Last updated by the study team

2026-02-20

Who can join

Age: 1 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 6 months -14 years
• Bilateral tympanostomy tube placement
• First tympanostomy tubes placement
• Indication for tympanostomy tube placement is otitis media

You may not qualify if…

• Undergoing tympanostomy tube placement for indication other than otitis media
• Receiving tubes other than Armstrong grommet.
• 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
• Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
• Caregivers who cannot speak, read, or write in English proficiently
• Prior or current otologic surgery other than tympanostomy tube placement
• On systemic corticosteroids at the time of enrollment
• Immunodeficiency (acquired or congenital)
• Current retraction, cholesteatoma, or middle ear mass
• Atresia
• Sensorineural hearing loss
• Known ossicular chain anomaly

Where it is running

• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh North — Sewickley, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.