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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

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Three Methods Used in the Diagnosis of EER in Children With OME
Official Title  ICMJE Comparison of Three Methods Used in the Diagnosis of Extraesophageal Reflux in Children With Chronic Otitis Media With Effusion
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Otitis Media With Effusion
  • Laryngopharyngeal Reflux
Intervention  ICMJE
  • Other: Restech
  • Other: Peptest
  • Other: Detection of pepsin in adenoid specimen
Study Arms  ICMJE 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.
Interventions:
  • Other: Restech
  • Other: Peptest
  • Other: Detection of pepsin in adenoid specimen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2014)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02183961
Other Study ID Numbers  ICMJE FNO-ENT-EER Peptest Restech
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Ostrava
Study Sponsor  ICMJE University Hospital Ostrava
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Formánek, MD University Hospital Ostrava
PRS Account University Hospital Ostrava
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP