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Completed

NCT Number: NCT02183974

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.

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Key information

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signing of the informed consent
  • children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME

Exclusion criteria

  • children with craniofacial abnormities (Down syndrome, Treacher Collins syndrome, clefts etc.)

Treatment and study plan

Peptest

Procedure

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 8, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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