Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion
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|ClinicalTrials.gov Identifier: NCT02183974|
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media With Effusion||Procedure: Peptest||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||May 2014|
44 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. Effusion was collected and analysed 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).
- The frequency of the presence of pepsin in effusion in the middle ear as an indirect diagnostic method of extraesophageal reflux in children with otitis media with effusion [ Time Frame: 2 years ]The frequency of the presence of pepsin in effusion in the middle ear was detected using Peptest in children with OME
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183974
|University Hospital Ostrava|
|Ostrava, Moravian-Silesian Region, Czech Republic, 708 52|
|Principal Investigator:||Martin Formánek, MD||University Hospital Ostrava|