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

Otitis Media With Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183974
• Other study ID #: FNO-ENT-OME Restech
• Status: Completed
• Phase: N/A
• First received: July 2, 2014
• Last updated: July 2, 2014
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 7 Years

Eligibility

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.)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Procedure:
• Peptest

Locations

Country	Name	City	State
Czech Republic	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czech Republic, 

References & Publications (3)

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No