Otitis Media With Effusion Clinical Trial
Official title:
Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion
Verified date | July 2014 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | Czech Republic: Ethics Committee |
Study type | Interventional |
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.
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.) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Czech Republic | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czech Republic,
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, MatouĊĦek 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
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 |
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