Status:
ACTIVE_NOT_RECRUITING
Posterior Vs. Anterior Tympanostomy Tube Placement
Lead Sponsor:
David Chi, MD
Conditions:
Otitis Media in Children
Chronic Otitis Media with Effusion
Eligibility:
All Genders
6-14 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
The tympanic membrane can be divided into quadrants: posterior superior, anterior superior, posterior inferior, and anterior inferior. Traditional training dictates that tympanostomy tubes should be p...
Eligibility Criteria
Inclusion
- Ages 6 months -14 years
- Bilateral tympanostomy tube placement
- First tympanostomy tubes placement
- Indication for tympanostomy tube placement is otitis media
Exclusion
- 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
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT06191562
Start Date
February 29 2024
End Date
February 1 2028
Last Update
February 20 2025
Active Locations (2)
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1
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
2
UPMC Children's Hospital of Pittsburgh North
Sewickley, Pennsylvania, United States, 15143