OBJECTIVES/HYPOTHESIS: Gastroesophageal reflux disease (GERD) is common in children, and extraesophageal reflux disease (EORD) has been implicated in the pathophysiology of otitis media (OM). We sought to 1) determine the incidence of pepsin/pepsinogen presence in the middle ear cleft of a large sample of pediatric patients undergoing myringotomy with tube placement for OM; 2) compare this with a control population of pediatric patients undergoing middle ear surgery (cochlear implantation) with no documented history of OM; 3) analyze potential risk factors for OM in children with EORD demonstrated by the presence of pepsin in the middle ear cleft; and 4) determine if pepsin positivity at the time of myringotomy with tube placement predisposes to posttympanostomy tube otorrhea. STUDY DESIGN AND METHODS: Study Group: prospective samples of 509 pediatric patients (n = 893 ear samples) undergoing myringotomy with tube placement for recurrent acute OM and/or otitis media with effusion in a tertiary care pediatric hospital with longitudinal follow-up of posttympanostomy tube otorrhea. Control Group: prospective samples of 64 pediatric patients (n = 74 ears) with negative history of OM undergoing cochlear implantation at one of the three tertiary care pediatric hospitals. A previously validated, highly sensitive and specific modified enzymatic assay was used to detect the presence of pepsin in the middle ear aspirates of study and control patients. Risk factors for OM and potentially associated conditions, including GERD, allergy, and asthma were analyzed for the study group through review of the electronic medical record and correlated topresence of pepsin in the middle ear space. Study patients were followed longitudinally postoperatively to determine the incidence of posttympanostomy tube otorrhea. RESULTS: The incidence of pepsin in the middle ear cleft of the study group was 20% of patients and 14% of ears, which is significantly higher than 1.4% of control patients and 1.5% of control ears (P < .05). Study patients younger than 1 year had a higher rate of purulent effusions and pepsin in the middle ear cleft (P < .05). Patients with pepsin in the middle ear cleft were more likely to have an effusion at the time of surgery than patients without pepsin in the middle ear cleft (P < .05). There was no statistical association found between the presence of pepsin and clinical history of GERD, allergy, asthma, or posttympanostomy tube otorrhea. CONCLUSIONS: Pepsin is detectable in the middle ear cleft of 20% of pediatric patients with OM undergoing tympanostomy tube placement, compared with 1.4% of controls; recovery of pepsin in the middle ear space of pediatric patients with OM is an independent risk factor for OM. Patients under 1 year of age have a higher incidence of purulent effusions and pepsin-positive effusions. Clinical history of GERD, allergy, and asthma do not seem to correlate with evidence of EORD reaching the middle ear cleft. The presence of pepsin in the middle ear space at the time of tube placement does not seem to predispose to posttympanostomy tube otorrhea.
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