The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Patients previously managed by ventilation tube. Those who had cleft palate. The patients were divided into three equal groups. In group 1, 20 patients will be received steroids spray, for. 2 months In group 2, 20 patients will be received steroids for 1 month In group 3, 20 patients will be receive hypertonic sea water solution Otoscopic examination, basic audiological evaluation including pure tone audiometry, and immittancemetry will be performed before treatment and repeated at 3 and 6 months after treatment. The evaluation was performed using ORBITR 922 VERSION2 . Examiners will be blinded to the type of treatment. 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.

Official Title
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The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study

Conditions
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Otitis Media With Effusion

Intervention / Treatment
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* Drug: Mometasone Furoate spray
* Drug: prednisolone sodium phosphate 15mg
* Drug: hypertonic sea water solution spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: momestone furoate spray first group: will be given<br>Nasonex spray one puff in each nostril daily for 8 weeks | Drug: Mometasone Furoate spray<br>* 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.<br>|
| Placebo Comparator: prednisolone sodium phosphate 15mg second group: will be given<br>Predsol fort tablet three times per day for 1 week then gradual withdrawal over 2 weeks | Drug: prednisolone sodium phosphate 15mg<br>* three times per day for 1 week then gradual withdrawal over 2 weeks<br>|
| Placebo Comparator: hypertonic sea water solution spray third group: will be given<br>Nasal spray one puff in each nostril daily for 8 weeks | Drug: hypertonic sea water solution spray<br>* one puff in each nostril daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Otitis Media with Effusion