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

• ClinicalTrials.gov Identifier: NCT02183974
• Recruitment Status: Completed
• First Posted: July 8, 2014
• Last Update Posted: July 8, 2014
• Sponsor: University Hospital Ostrava
• Information provided by (Responsible Party): University Hospital Ostrava

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.

Condition or disease	Intervention/treatment	Phase
Otitis Media With Effusion	Procedure: Peptest	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Peptest; 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).	Procedure: Peptest

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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.)

Contacts and Locations

Locations

Czech Republic

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czech Republic, 708 52

Sponsors and Collaborators

University Hospital Ostrava

Investigators

• Principal Investigator: Martin Formánek, MD; University Hospital Ostrava

More Information

Publications:

Zeleník K, Matoušek P, Urban O, Schwarz P, Stárek I, Komínek 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.

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. Review.

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.

• Responsible Party: University Hospital Ostrava
• ClinicalTrials.gov Identifier: NCT02183974 History of Changes
• Other Study ID Numbers: FNO-ENT-OME Restech
• First Posted: July 8, 2014
• Last Update Posted: July 8, 2014
• Last Verified: July 2014

Keywords provided by University Hospital Ostrava:

otitis media with effusion; Laryngopharyngeal Reflux

Additional relevant MeSH terms:

Otitis; Otitis Media; Otitis Media with Effusion; Ear Diseases; Otorhinolaryngologic Diseases