Food Allergy - Tubes - Adenoids (FATA) Trial

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 correction of OME by a BMT (Bilateral Myringotomy with Tympanostomy Tubes) +/- Adenoidectomy, with additional food allergy diagnosis and subsequent management of offending foods in order to reduce the frequency of recurrent otitis media (ROM). End Points: Comparison between groups (1,2,3) on the recurrence of otitis media following surgery. All trial participants will have follow-up clinic appointments every three months until tubes fall out and after this point, patients will present to clinic every three months for one year for evaluation of recurrent middle ear fluid. Questionnaires will be administered to Groups 2 \& 3 at the F/U appointments to evaluate food allergy management. Methodology: Trial participants will be identified by their otitis media signs and symptoms. Subjects who meet the inclusion criteria will be asked to participate in the study and consent will be obtained. Surgery will be performed based on group assignment. All trial subjects will receive standard post-op care and will also be seen for clinical evaluation q 3 months post-surgery, and then q 3 months after the tubes are out for one year. The number of otitis media episodes during the follow up year in children assigned to groups 1,2, and 3 will be recorded. Procedures: At the initial clinic visit, potential trial subjects will be asked about their otitis media history, including how many episodes of OM in the past six months, evidence of hearing loss, lack of response to antibiotic therapy, prolonged periods of OME, and previous tympanograms. Pediatric patients will have their tympanic membranes (TM) evaluated by otoscopy for evidence of OME. Tympanometry will also be performed to confirm the presence of fluid in the middle ear. Participants in the control group (Group 1) will receive the standard academy regimen for initial presentation of Chronic OME, which is insertion of BMT. Group 2 trial subjects will receive food allergy testing and management in conjunction with BMT. Group 3 involves BMT insertion, adenoidectomy, and food allergy testing and management. Food management involves parental education on how to avoid the specific offending foods by their allergic children. The total length of subject participation is variable depending on when the tubes come out. Once the tubes have fallen out, the patient will be evaluated every three months for one full year.