Three Methods Used in the Diagnosis of EER in Children With OME
Condition: Otitis Media With Effusion; Laryngopharyngeal Reflux
MeSH terms: Laryngopharyngeal Reflux; Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional

Summary: 
      Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion
      (OME) using three different diagnostic methods and selection of the group of patients with
      severe EER who could potentially benefit from antireflux therapy.
    

Detailed description: 
      Children aged between 1 and 7 years diagnosed with bilateral or unilateral OME who underwent
      adenoidectomy and myringotomy with insertion of a ventilation tube were included in the
      prospective study. OME was defined as effusion in the middle ear behind an intact eardrum for
      longer than 3 months. Diagnosis was made on the basis of otomicroscopic findings, pneumatic
      otoscopy, type B tympanometry and audiometry (in older, cooperative children). Children with
      no fluid in the middle ear during myringotomy were re-diagnosed as having tympanosclerosis
      and were excluded from the study. Children with craniofacial abnormalities (Down syndrome,
      Treacher Collins syndrome, clefts etc.) were excluded from the study as well. Demographic
      data and symptoms of EER disease were provided by parents, who were specifically asked about
      hoarseness, recurrent lower respiratory infections (bronchitis, pneumonia) and bronchial
      asthma in their child.

      24 hour monitoring of oropharyngeal pH using the Restech system was performed before surgery.
      Parents were instructed to record the time their child spent eating, drinking and in a
      horizontal position directly to the device and manually to the diary. If there was any
      discrepancy, periods logged in the device were modified according to the diary. A
      standardized RYAN composite score was calculated automatically using the software supplied.
      Patients with pathological RYAN composite scores in the vertical (higher than 9.4) and/or
      horizontal (higher than 6.8) position were classified as having pathological EER. Severe EER
      was diagnosed when the RYAN composite score in the vertical or horizontal position was higher
      than 200.

      Myringotomy using a microscope was done on the anterior inferior part of the tympanic
      membrane. The type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid
      was collected using a special suction device with a collecting bottle, and a ventilation tube
      was inserted in the tympanic membrane. In the case of bilateral OME, middle ear fluids were
      collected and analysed separately. The specimen was first standardized. 0.1 ml of 10% citric
      acid was added, the specimen was centrifuged for 10 minutes and subsequently the original
      migration reagent was added. Afterwards, the specimen was examined using Peptest, which
      contains monoclonal antibodies that target pepsin. The result of the Peptest was given as
      positive (2 lines), negative (1 line) or invalid (no line).

      Then, adenoidectomy using a cold instrument was performed. A specimen of adenoids (5x5x5mm)
      from the area close to the torus tubarius was fixed in formaldehyde and immunohistochemically
      analysed at the Department of Pathology. Antibody P3635Rb-h (Uscnlife, USA, concentration
      1:100) was used as the primary antibody. Antibody N-HistofineSimple Stain MAX PO (Nichirei
      Biosciences Inc.) was used as the secondary antibody.

      Statistical analysis was done using MS Excel.
    

Intervention name(s): Restech; Peptest; Detection of pepsin in adenoid specimen
Intervention type(s): Other; Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: otitis media with effusion; peptest; restech; oropharyngeal pH monitoring; laryngopharyngeal reflux