Otitis Media With Effusion Clinical Trial
— EfficacyOfficial title:
The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study
Otitis media with effusion (OME) is defined as effusion in the middle ear without signs and symptoms of an acute infection. It is a leading cause of hearing impairment in children, and its early and proper management can avoid hearing and speech impairment, which can cause developmental delay in children.Although many conditions such as enlarged adenoids, cleft palate, Down syndrome, Kartagener syndrome, and nasopharyngeal neoplasm are related to the role of eustachian tube (ET) dysfunction in the pathogenesis of OME, allergic, immunologic, and infectious factors have also been claimed. Treatment of OME is still a controversial issue, as conventional treatment approaches fail to provide satisfactory and permanent relief of otologic symptoms.There is lack of proven effectiveness of the commonly given treatments, such as antibiotics, decongestants, and antihistamines, which are potentially harmful and have disadvantages. Few in those studies,investigated topical intranasal steroid for OME treatment,and in those studies, the duration of intranasal steroid application was short and there was no hearing evaluation.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | March 1, 2020 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Sixty patients (4-12) years aged children with OME over a period for two months. Exclusion Criteria: - Patients previously managed by ventilation tube. - Those who had cleft palate. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Muteea Mubark Salmen Bakuwiri |
Bernstein JM, Lee J, Conboy K, Ellis E, Li P. Further observations on the role of IgE-mediated hypersensitivity in recurrent otitis media with effusion. Otolaryngol Head Neck Surg. 1985 Oct;93(5):611-5. — View Citation
Ho WK, Wei WI, Yuen AP, Hui Y, Wong SH. Otorrhea after grommet insertion for middle ear effusion in patients with nasopharyngeal carcinoma. Am J Otolaryngol. 1999 Jan-Feb;20(1):12-5. — View Citation
Tang NL, Choy AT, John DG, van Hasselt CA. The otological status of patients with nasopharyngeal carcinoma after megavoltage radiotherapy. J Laryngol Otol. 1992 Dec;106(12):1055-8. — View Citation
Tomonaga K, Kurono Y, Chaen T, Mogi G. Adenoids and otitis media with effusion: nasopharyngeal flora. Am J Otolaryngol. 1989 May-Jun;10(3):204-7. — View Citation
Yousaf M, Inayatullah, Khan F. Medical versus surgical management of otitis media with effusion in children. J Ayub Med Coll Abbottabad. 2012 Jan-Mar;24(1):83-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical examination:Hearing loss | Hearing loss,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present, | 2 weeks evaluation for 2 months | |
Primary | Clinical examination:Nasal obstruction | Nasal obstruction,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present, | 2 weeks evaluation for 2 months | |
Primary | Full E.N.T history | Snoring ,sleep apnea ,difficult suckling in infants,anterior nasal discharge and conductive hearing loss. | 2 weeks evaluation for 2 months |
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