NCT02183961|Completed
Three Methods Used in the Diagnosis of EER in Children With OME
Comparison of Three Methods Used in the Diagnosis of Extraesophageal Reflux in Children With Chronic Otitis Media With Effusion
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Comparison of Three Methods Used in the Diagnosis of Extraesophageal Reflux in Children With Chronic Otitis Media With Effusion
Sponsor study identifier
interventional
24
1 country
1
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
May 2014
Actual (reported)Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion (OME) using three different diagnostic methods and selection of the group of patients with severe EER who could potentially benefit from antireflux therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 2014
Actual (reported)May 2014
Actual (reported)July 2, 2014
Actual (reported)July 8, 2014
Actual (reported)The frequency of the extraesophageal reflux in children with otitis media with effusion measured with three different methods
Children between 1 to 7 years diagnosed with OME who underwent adenoidectomy and myringotomy with insertion of a ventilation tube were included in this prospective study. EER was detected using three methods: oropharyngeal pH was monitored for 24 hours using the Restech system; detection of pepsin in middle ear fluid obtained during myringotomy was done using Peptest, and detection of pepsin in an adenoid specimen was done immunohistochemically using antibody P3635Rb-h.
2 years
EER was detected using three methods: oropharyngeal pH was monitored for 24 hours using the Restech system; detection of pepsin in middle ear fluid obtained during myringotomy was done using Peptest, and detection of pepsin in adenoid specimen was done immunohistochemically using antibody P3635Rb-h.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52, Czechia
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.
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.
Martin Formánek, MD
University Hospital Ostrava
24 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2014
First Posted
July 8, 2014
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Individualized Diagnosis and Treatment of Extraesophageal Reflux in Patients With Chronic Cough
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Jiang A, Liang M, Su Z, Chai L, Lei W, Wang Z, Wang A, Wen W, Chen M. Immunohistochemical detection of pepsin in laryngeal mucosa for diagnosing laryngopharyngeal reflux. Laryngoscope. 2011 Jul;121(7):1426-30. doi: 10.1002/lary.21809. Epub 2011 Jun 6.
Wiener GJ, Tsukashima R, Kelly C, Wolf E, Schmeltzer M, Bankert C, Fisk L, Vaezi M. Oropharyngeal pH monitoring for the detection of liquid and aerosolized supraesophageal gastric reflux. J Voice. 2009 Jul;23(4):498-504. doi: 10.1016/j.jvoice.2007.12.005. Epub 2008 May 12.
Primary Completion
March 2014
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
July 8, 2014
Record last verified: 2014-07
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