Research
Acute Otitis Media (AOM) NIH Clinical Trial
A “watchful waiting” approach for children with acute otitis media (AOM) has been the standard of care over the last 10 years in several European countries, in some instances, for children as young as six months of age. However, most reports endorsing watchful waiting are based on meta-analyses, which include trials characterized by numerous and serious methodological limitations.
Recently published AOM management guidelines jointly developed by the American Academy of Pediatrics and the American Academy of Family Physicians endorsed this watchful waiting approach in children 6-24 months with non-severe disease and uncertain diagnosis, and in children older than 24 months with non-severe disease regardless of certainty of diagnosis.
Protocol Description
This carefully designed clinical trial in children 6-23 months will address an issue of particular concern that has not been satisfactorily addressed in previous studies: whether antimicrobial treatment along with analgesic treatment offers young children with AOM an earlier and more complete overall clinical improvement (including relief of discomfort) than analgesic treatment alone. This earlier and more complete improvement may constitute the most important benefit of antimicrobial treatment.
Benefits:
During the study, there will be no charge for visits or medications. The staff will maintain close follow-up of your child's ear infection. In addition, a staff member will be available by phone 24 hours a day.
Eligibility Criteria
Patients with the presence of an ear infection that has not received treatment.
Boys: 6 to 23 Months
Girls: 6 to 23 Months
Requirements
Visits: 4
Duration: 1 month
Status: Open for enrollment
Toolkit for Physicians
How to refer your next patient with AOM:
- Call Dr. Hoberman at 412-999-EARS (3277).
- Provide parents with the “Letter to Parents and Directions to Oakland Medical Building,” below.
- Your patient will be seen immediately upon his or her arrival at Children’s Primary Care Center.
Letter to Physicians (PDF)
Letter to Parents and Directions to Oakland Medical Building (PDF)
Important Points to Discuss with Parents (PDF)
AOM Study Poster (PDF)
Rapid Learning Option
View excerpt from AOM Web cast related to NIH clinical trial. (Real Player required.)
Additional Resources:
- AOM Clinical Trial (NIH Web site)
- ePROM: Diagnosis of OME
- ePROM: Diagnosis of AOM
- DxEar: Standardization of AOM Diagnosis (AOM, OME, normal middle ear status video clips)
User name: demo
Password: demo
CME Option
View the AOM Web cast replay:
Primary Investigator(s)
Alejandro Hoberman, MD
Contact Information
To get started, please contact:
412-999-EARS (3277)
