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Thank you for your interest in this study. AOM is the most frequently diagnosed illness in children and the most common reason for being prescribed an antibiotic. In our study funded by the National Institutes of Health and published in the New England Journal of Medicine, researchers at Children’s Hospital of Pittsburgh of UPMC determined that children who received antibiotics responded significantly faster and were less likely to have persistent otoscopic signs of an ear infection at the end of treatment. This benefit, however, must be weighed against concern not only about side effects (diarrhea, diaper rash), but also about the contribution of antibiotic treatment to the emergence of bacterial resistance. These considerations underscore the need to restrict treatment to children whose illness is diagnosed using stringent criteria. As part of a broader initiative of clinical trials to fight antimicrobial resistance, NIH funded our center to determine whether children 6 to 24 months with AOM can be effectively treated with 5 days instead of 10 days of antibiotics. A shorter treatment course may be beneficial in reducing antibiotic resistance and reducing the likelihood of side effects. The results of this trial are currently being analyzed.
Most recently NIH has funded our center to determine the efficacy of tympanostomy tube placement for young children with recurrent acute otitis media. The efficacy of tympanostomy tubes, assumedly by maintaining middle-ear ventilation, remains unclear, and the benefits of tubes must be balanced against risks of anesthesia, complications and sequelae of surgery, and cost. In a phase 3 randomized, clinical trial, children aged 6-35 months who are at risk for rAOM will be followed prospectively and examined promptly with new respiratory illnesses to accurately document episodes of AOM. At that time, they will be randomized to tympanostomy tubes or nonsurgical management and followed for 2 years. We will compare the average number of ear infections, changes in nasopharyngeal colonization and cost-effectiveness of each approach. Findings of this new study will provide clinicians and parents with dependable evidence concerning the overall effects of tympanostomy tubes compared with nonsurgical management in children with rAOM of varying degrees of severity, enabling evidence-based decisions regarding an important component of the children’s healthcare.
For more information, please read this Letter to Physicians (PDF) or see https://trialspark.com/#/trials/chpaomstudy.
Below are links to information to enable full understanding of this research and to help with patient education and participation in this clinical study.
If you are not one of the participating PittNet sites and wish to refer a patient to the study, please:
Study Description at National Institutes of Health
NEJM: Treatment of AOM in Children Under 2 Years of Age
NEJM Article Supplementary Material
NEJM Video: Diagnosing Otitis Media – Otoscopy and Cerumen Removal
NEJM Video: Tympanocentesis in Children with Acute Otitis Media
Recent Study Featured in NIH News in Health
Acute Otitis Media in Children Younger Than 2 Years (JAMA)
AOM in Kids: New Treatments, New Questions (MedScape) – login required
AOM Grand Rounds Presentation by Alejandro Hoberman, MD, Oct. 2010.
Note: CME credits are available for Modules 2 and 3 above, but require a login at PedsEd – Pediatrics Education (Registration is free.)
Key Study Points (PDF)
Letter to Physicians (PDF)
Letter to Parents and Directions to Oakland Medical Building (PDF)
AOM Study Poster (PDF)
AOM Study Consent Form (PDF)
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UPMC Children’s Hospital of Pittsburgh One Children’s Hospital Way 4401 Penn Ave. Pittsburgh, PA 15224
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