Status:
WITHDRAWN
Food Allergy - Tubes - Adenoids (FATA) Trial
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Otitis Media With Effusion
Food Hypersensitivity
Eligibility:
All Genders
Up to 4 years
Phase:
NA
Brief Summary
The questioned proposed by this study is one of treatment: "To what extent does simultaneous BMT (Bilateral Myringotomy with Tympanostomy Tubes), adenoidectomy, and diagnosis/avoidance of food allergy...
Detailed Description
Design: Randomized controlled trial to evaluate the efficacy of a new approach in the treatment of children presenting with chronic otitis media with effusion. The new approach calls for a surgical co...
Eligibility Criteria
Inclusion
- Otoscopy reveals Chronic OME.
- Tympanometry confirms fluid in middle ear.
- Children \<4 years old
- Lack of improvement after three months of antibiotic therapy.
- History of persistent effusion for three or more months per-episode of OM.
- \>3 episodes of AOM in preceding 6 months or \>5 episodes of AOM during preceding 12 months
- Bilateral conductive hearing loss of 15 dB or more.
Exclusion
- Previous adenotonsillar surgery or placement of tympanostomy tubes.
- Children with inhalant allergies including asthma.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00736112
Start Date
October 1 2008
End Date
May 1 2015
Last Update
September 30 2016
Active Locations (1)
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1
University Hospital: Department of Otolaryngology - Head and Neck Surgery
Columbia, Missouri, United States, 65212