An Early Phase 1 interventional study of Mometasone Furoate spray and prednisolone sodium phosphate 15mg in Otitis Media With Effusion, sponsored by Muteea Mubark Salmen Bakuwiri. Status unknown. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by Muteea Mubark Salmen Bakuwiri · Early Phase 1, Interventional, and Treatment
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.
The aim of this study is to assess the efficacy of nasal steroids in management of OME by comparing its results with that of oral steroids and that of nasal saline spray.
Sixty patients (4-12) years aged children with OME over a period for two months will be included in this study. Informed written consent will obtained from the parents of patient studied after explanation of the research purpose.
Patient diagnosed clinically to have OME with type B tympanogram and conductive hearing loss will be enrolled in our study.
Exclusion criteria:
Tympanometry results were distinguished into four grades as classified by El-Anwar et al12: type A, normal curve (pressure 50/_99 H2O); type C1 (negative pressure _100/_199 mm H2O); type C2 (negative pressure _200/_394 mm H2O); type B (flat curve).2,3,11 The average hearing thresholds at 500 Hz and 1, 2, and 4 kHz were used in the statistical comparison.
Follow-up clinical examinations were done once per week for 3 weeks, at the end of treatment. The efficacy of nasal steroid for management of OME was compared with that of oral steroid and that of nasal sinomarin spray as placebo.
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
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Exclusion Criteria:
Nasonex spray one puff in each nostril daily for 8 weeks
Drug: Mometasone Furoate spray
Predsol fort tablet three times per day for 1 week then gradual withdrawal over 2 weeks
Drug: prednisolone sodium phosphate 15mg
Nasal spray one puff in each nostril daily for 8 weeks
Drug: hypertonic sea water solution spray
Mometasone Furoate spray one puff in each nostril daily for 8 weeks hypertonic sea water solution spray one puff in each nostril daily for (8) weeks.
three times per day for 1 week then gradual withdrawal over 2 weeks
one puff in each nostril daily for 8 weeks
Clinical examination:Hearing loss
Hearing loss,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,
Time frame: 2 weeks evaluation for 2 months
Clinical examination:Nasal obstruction
Nasal obstruction,0=no symptoms,1= present 2 weeks ,3=present daily,4=always present,
Time frame: 2 weeks evaluation for 2 months
Full E.N.T history
Snoring ,sleep apnea ,difficult suckling in infants,anterior nasal discharge and conductive hearing loss.
Time frame: 2 weeks evaluation for 2 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for May 2018; primary completion for Apr 2019, 11 months later.
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This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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