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Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion

Primary Purpose

Otitis Media With Effusion

Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Peptest
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Otitis Media With Effusion focused on measuring otitis media with effusion, Laryngopharyngeal Reflux

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peptest

Arm Description

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).

Outcomes

Primary Outcome Measures

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
The frequency of the presence of pepsin in effusion in the middle ear was detected using Peptest in children with OME

Secondary Outcome Measures

Full Information

First Posted
July 2, 2014
Last Updated
July 2, 2014
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT02183974
Brief Title
Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion
Official Title
Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion
Keywords
otitis media with effusion, Laryngopharyngeal Reflux

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peptest
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Peptest
Primary Outcome Measure Information:
Title
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
Description
The frequency of the presence of pepsin in effusion in the middle ear was detected using Peptest in children with OME
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Formánek, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
708 52
Country
Czech Republic

12. IPD Sharing Statement

Citations:
PubMed Identifier
20938965
Citation
Zelenik K, Matousek P, Urban O, Schwarz P, Starek I, Kominek P. Globus pharyngeus and extraesophageal reflux: simultaneous pH <4.0 and pH <5.0 analysis. Laryngoscope. 2010 Nov;120(11):2160-4. doi: 10.1002/lary.21147.
Results Reference
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PubMed Identifier
18940143
Citation
He Z, O'Reilly RC, Mehta D. Gastric pepsin in middle ear fluid of children with otitis media: clinical implications. Curr Allergy Asthma Rep. 2008 Nov;8(6):513-8. doi: 10.1007/s11882-008-0094-7.
Results Reference
background
PubMed Identifier
18594333
Citation
O'Reilly RC, He Z, Bloedon E, Papsin B, Lundy L, Bolling L, Soundar S, Cook S, Reilly JS, Schmidt R, Deutsch ES, Barth P, Mehta DI. The role of extraesophageal reflux in otitis media in infants and children. Laryngoscope. 2008 Jul;118(7 Part 2 Suppl 116):1-9. doi: 10.1097/MLG.0b013e31817924a3.
Results Reference
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Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion

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