کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
11030757 1646160 2018 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Efficacy of a non-invasive middle ear aeration device in children with recurrent otitis media: A randomized controlled trial protocol
ترجمه فارسی عنوان
اثربخشی دستگاه هوادهی غیر تهاجمی در کودکان مبتلا به اوتیت مجدد: یک پروتکل کنترل شده تصادفی
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی علوم دارویی
چکیده انگلیسی
Acute otitis media (AOM) represents a significant disease burden in the pediatric population. Besides vaccinations, there are no robust measures of reducing incidence of AOM in this age-group. This is a randomized controlled clinical trial evaluating the efficacy of a non-invasive middle ear aeration device, the EarPopper device (EP). We aim to investigate the reduction of episodes AOM in children with recurrent otitis media. The control arm will be observational. The intervention arm will have the EP used. The primary endpoint is incidence of AOM. The secondary endpoints are hazard ratio of time to AOM, proportion without AOM and antibiotics use, quality of life (OMO-22 Form), and adherence to treatment. Sample size is a minimum of 150 patients. The inclusion criteria is ages 4-11, with history of recurrent Acute Otitis Media (AOM).
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Contemporary Clinical Trials Communications - Volume 12, December 2018, Pages 92-97
نویسندگان
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