Otitis Media With Effusion Clinical Trial
Official title:
Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion
The aim of the study was detection of pepsin in effusion in children with OME using Peptest as new quick and cheap method of detection and comparison results with results of other studies in which pepsin was detected by more demanding methods. Such a type of study hasn't been done so far.
Children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME who
underwent adenoidectomy and myringotomy with insertion of ventilation tube were included in
the prospective study. OME was defined as effusion in the middle ear behind intact eardrum
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 middle ear during myringotomy were revised as having tympanosclerosis and were
excluded from the study. Children with craniofacial abnormities (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 particularly inquired regarding
the hoarseness, recurrent lower respiratory infection (bronchitis, pneumonia) and bronchial
asthma of their child.
Myringotomy using microscope was done in anterior inferior part of the tympanic membrane.
Type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid was collected
by special suction device with collecting bottle and ventilation tube was inserted in the
tympanic membrane. In case of bilateral OME, effusion was collected and analysed separately.
Specimen was first standardized. An amount of 0.1 ml of 10 % citric acid was added, specimen
was centrifuged for 10 minutes and subsequently original migration reagent was added.
Afterwards, specimen was examined using Peptest, which contains monoclonal antibodies
targeted against pepsin. Result of the Peptest was stated as positive (2 lines), negative (1
line) and invalid (no line). Peptest detection limit is 16ng/ml of pepsin. Statistical
analysis was done using MS Excel.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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