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

NCT ID: NCT02183974

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-05-31

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.

Conditions

Otitis Media With Effusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Peptest

Intervention Type: PROCEDURE

Interventions

Peptest

Intervention Type: PROCEDURE

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.)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Formánek, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Countries

Czechia

References

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.

Reference Type: BACKGROUND

PMID: 20938965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18940143 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18594333 (View on PubMed)

Other Identifiers

FNO-ENT-OME Restech

Identifier Type: -

Identifier Source: org_study_id