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Three Methods Used in the Diagnosis of EER in Children With OME

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ClinicalTrials.gov Identifier: NCT02183961
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

Brief 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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Laryngopharyngeal Reflux Other: Restech Other: Peptest Other: Detection of pepsin in adenoid specimen Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Three Methods Used in the Diagnosis of Extraesophageal Reflux in Children With Chronic Otitis Media With Effusion
Study Start Date : June 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Pepsin

Arm Intervention/treatment
Experimental: Laryngopharyngeal reflux
EER was detected using three methods: oropharyngeal pH was monitored for 24 hours using the Restech system; detection of pepsin in middle ear fluid obtained during myringotomy was done using Peptest, and detection of pepsin in adenoid specimen was done immunohistochemically using antibody P3635Rb-h.
Other: Restech
Other: Peptest
Other: Detection of pepsin in adenoid specimen



Primary Outcome Measures :
  1. The frequency of the extraesophageal reflux in children with otitis media with effusion measured with three different methods [ Time Frame: 2 years ]
    Children between 1 to 7 years diagnosed with OME who underwent adenoidectomy and myringotomy with insertion of a ventilation tube were included in this prospective study. EER was detected using three methods: oropharyngeal pH was monitored for 24 hours using the Restech system; detection of pepsin in middle ear fluid obtained during myringotomy was done using Peptest, and detection of pepsin in an adenoid specimen was done immunohistochemically using antibody P3635Rb-h.



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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with otitis media with effusion
  • age 1-7 years
  • signing of the informed consent

Exclusion Criteria:

- children with craniofacial abnormalities (Down syndrome, Treacher Collins syndrome, clefts etc.)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183961


Locations
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Czech Republic
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czech Republic, 708 52
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Martin Formánek, MD University Hospital Ostrava

Publications:
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02183961     History of Changes
Other Study ID Numbers: FNO-ENT-EER Peptest Restech
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by University Hospital Ostrava:
otitis media with effusion
peptest
restech
oropharyngeal pH monitoring
laryngopharyngeal reflux
Additional relevant MeSH terms:
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Laryngopharyngeal Reflux
Otitis
Otitis Media
Otitis Media with Effusion
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Pepsin A
Gastrointestinal Agents