Clinical Trial: Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Role of Empiric Anti-reflux Therapy in Pediatric Otitis Media With Effusion - a Pilot Study
Brief Summary:
The accumulation of fluid behind the ear drum without any acute inflammation is known as otitis media with effusion (OME). It is the most common cause of acquired hearing loss during childhood. Long-term complications of OME include linguistic, developmental, and social development delays due to hearing loss.
The cause of OME is not known; however, low grade infection of the middle ear, poor function of the eustachian tube between the ear and the throat, and adenoid hypertrophy have all been suggested as possible etiologies. Recent detection of the stomach enzyme pepsin in middle ear fluid has led some to propose that OME is related to the reflux of stomach contents into the ear, via the eustachian tube.
The purpose of the investigators study is to determine whether anti-reflux medication may have a positive impact by clearing the accumulation of fluid in the middle ear with the aim of preventing or reducing hearing loss in children diagnosed with OME. Empiric anti-reflux therapy with proton pump inhibitor (PPI) medication is safe, proven and cost-effective. It is used widely as a diagnostic and treatment strategy in the presence of the signs and symptoms of gastroesophageal reflux disease (GERD). The signs and symptoms of GERD include heartburn, recurrent vomiting or regurgitation, acid taste in mouth, throat irritation, voice problems, heartburn, difficult or painful swallowing, asthma and recurrent pneumonia.
This pilot study will be a double-blinded, randomized, placebo-controlled trial that will compare resolution rates for OME in children treated with lansoprazole or placebo for three months. At the end of the study, those patients who have persistent middle ear effusions will be brought to the operating room and have the fluid aspirated and sent for analysis for peps
Detailed Summary:
Otitis media with effusion (OME) is a condition characterized by the accumulation of non-purulent fluid in the middle ear space, in the absence of acute inflammation. OME is diagnosed 2.2 million times annually (U.S. Department of Health & Human Services, 2000). It is a condition in which more then 50% of children will experience in their first year of life (National Institutes of Health, 1993). Although many episodes resolve spontaneously, 30% to 40% persist, and 5% to 10% of episodes last 1 year or longer (Yoshinaga-Itano, 1995). It is particularly more common among children between the ages of one and three years and in seasons where the prevalence of upper respiratory tract infections is high; with an incidence of 10% to 30%. It occurs frequently even up to the age of seven, with a prevalence of 3% to 8%(Fiellau et al, 1997; Fiellau et al, 1983; Lous et al, 1981; Teele et al, 1989).
OME is the most common cause of acquired hearing loss in childhood. Long-term hearing complications from OME are associated with linguistic, developmental, and social consequences; especially if the OME is bilateral and of long duration (Fiellau et al, 1983; Golz et al, 1998; Grace et al, 1990; Lous et al, 1995). The etiology of OME is uncertain; however, low-grade infection, poor eustachian tube function, formation of biofilms, and adenoidal infection or hypertrophy have all been suggested as possible etiologies (Faden et al, 1998; Hall-Stoodley et al, 2006).
Recently, there has been good scientific evidence to suggest that OME is a supraesophageal manifestation of gastroesophageal reflux disease (GERD), and more specifically laryngo-pharyngeal reflux (LPR). Tasker et al (2002) investigated the potential role of gastric reflux in the development of OME in children who underwent myringotomy. Of 65 tested effusion samples, 59 (91%) effus
Sponsor: Hamilton Health Sciences Corporation
Current Primary Outcome: Collect the required data for sample size calculation [ Time Frame: Following the recruitment of 100 patients (~1 year) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Resolution of Otitis Media with Effusion [ Time Frame: At presentation and at 1 month, 2months and 3 months post initiation of treatment ]
Original Secondary Outcome: Same as current
Information By: McMaster University
Dates:
Date Received: March 4, 2010
Date Started: March 2010
Date Completion:
Last Updated: April 12, 2015
Last Verified: April 2015