9 Clinical Trials for Various Conditions
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops are the most effective, and whether a post-operative regimen should be used. Utilizing drops postoperatively places the onus of administration on parents who may have various difficulties in delivering the drops to their child's ears. Additionally, prescribing drops postoperatively is a health care cost. The purpose of this study is to determine if there is a difference in prevention of tympanostomy tube failure (defined as tube blockage or otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs administered once intraoperatively, and Ciprodex otic drops administered intraoperatively with a postoperative course.
This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.
A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
The purpose of this study is to evaluate the efficacy of three different surgical treatments (1. Bilateral myringotomy and tube insertion (M\&T); 2. Adenoidectomy and bilateral myringotomy (A\&T); 3. Adenoidectomy with myringotomy and tympanostomy tube insertion (A-M\&T)) in reducing subsequent episodes of middle ear disease and hearing loss caused by the fluid in the middle ear in children aged 24-47 months. The fluid in the middle ear is of at least three months' duration and unresponsive to standardized, recent antimicrobial treatment. The children are assigned to one of the three surgical treatments. After surgery, they are followed with examinations monthly and at the time of intercurrent infections for three years.
The goal of this randomized clinical trial is to compare the results of ear tube placement in two different parts of the ear drum. The ear drum can be divided into four parts (called quadrants). Ear tubes are usually placed in one section of the ear drum, called the anterior-inferior quadrant. However, tubes can also be placed in another section, called the posterior-inferior quadrant. Ear tubes usually fall out of the ear drum on their own. In most patients, the hole in the ear drum where the tube used to be closes on its own. Sometimes (in about 2% of patients), the hole does not close on its own and might need surgery. We want to study ear tube placement in the posterior-inferior quadrant because surgery to repair a hole in the eardrum is easier in this location. For this study, children will receive an ear tube in the usual location (anterior-inferior quadrant) in one ear and the new location (posterior-inferior quadrant) in the other ear. Researchers will determine which ear has the new location using random assignment (like flipping a coin). Researchers will collect information about hearing tests, whether there is ear drainage (otorrhea), if the tube is blocked (occluded), and how the ear drum looks for up to 37 months after tube placement. Participants will answer study questions at 2-12 weeks and 6, 12, 18, 24, 30, and 36 months after surgery. These questions will ask about whether tubes have fallen out of the ear drum, whether there is a hole in the ear drum, whether there has been drainage from the ear or other ear symptoms, and whether there have been any visits to the doctor for ear problems. Researchers will use this information to compare ears with anterior-inferior tube placement and ears with posterior-inferior tube placement to see if there are differences in common complications following tube placement.
The questioned proposed by this study is one of treatment: "To what extent does simultaneous BMT (Bilateral Myringotomy with Tympanostomy Tubes), adenoidectomy, and diagnosis/avoidance of food allergy affect the frequency of recurrent otitis media (ROM) versus the standard academy approach (tube insertions only) to chronic otitis media with effusion; furthermore, are adenoids a factor in OME or is food allergy diagnosis and treatment able to significantly prevent ROM after the tubes fall out?" The trial seeks to provide evidence that the treatment for Chronic OME in children should involve surgical procedures (BMT +/- adenoidectomy), as well, as a food allergy work-up and subsequent avoidance of the offending foods in order to significantly decrease ROM. To answer this question, a prospective, randomized controlled trial needs to be conducted. Since a majority of OME patients are from the pediatric population, parental consent must be obtained. Subjects in our study will initially present to the clinic with otitis media symptoms and diagnostic tests such as a tympanogram, otoscopy, and history of recurrent otitis media will be obtained. Once the surgical decision for bilateral myringotomy and tympanostomy tubes has been made, parents will be informed about the trial. The standard protocol for children presenting with initial Chronic OME is to perform a BMT. Therefore, data from the control group (Group 1) will be obtained from faculty ENT who follow the academy's recommendations. Data from Group 2 and 3 will be collected from other ENT faculty members, including the faculty co-investigator who will perform the BMT and obtain a food allergy blood draw at the time of surgery. The study's faculty co-investigator will describe food avoidance techniques to post-op patients from Groups 2 and 3. Patients with previous adenotonsillar surgery or placement of tympanostomy tubes will not be enrolled in the study. The incidence of ROM episodes in all trial groups will be recorded.
Middle-ear disease (infection and fluid) is the most common illness in young children after the common cold. Because hearing loss accompanies middle-ear disease, and because early life is a period of rapid development, concern has existed that sustained periods of middle-ear disease might cause lasting impairments of learning, speech development, language development, or behavior and social adjustment. Earlier phases of this research found that the insertion of ear tubes in children younger than 3 years of age with persistent middle-ear disease did not affect their development at 3, 4, or 6 years of age. This study examines the children's literacy, attention, and related abilities at 9 to 11 years of age.