Ear infections are common in babies and young children. They cause ear pain and sometimes fever. Without treatment, they may lead to repeated or chronic ear infections, infection of the bone surrounding the ear, and sometimes deafness. Repeated ear infections are the most common reason for needing surgery for ear tubes.
Ear infections are often treated with antibiotics. One problem in treatment is that the kinds of viruses or bacteria (germs) causing a child’s ear infection are not always known. Since different germs are treated with different kinds of antibiotics, these medicines don’t always work.
This is why researchers at the Rochester General Hospital (RGH) Research Institute are studying the different germs that cause ear infections, and are working on making better vaccines against the new kinds of germs that cause ear infections. They are also studying how the immune system works against ear infections, and why this does not work in some kids.
Eligible children will receive study-related tests and procedures at no cost. Compensation for your time to participate in the study will be provided.
What happens in the study?
Additional information will be taken regarding your child’s health and family history.
During your child’s well-child visits to your pediatrician, samples from your baby’s nose will be collected using a small swab similar to a Q-tip, and salt water will be used to rinse the nose of mucus. These procedures are similar to the tests done in the office to find out what germs are causing colds.
At 2 points in the study, 1 teaspoon of blood will be drawn from a vein. This will be done at the same time as your health care provider may need blood tests for routine care. The extra blood for the study will be used for research of the immune system.
When your baby has an ear infection, in addition to the nose and blood samples, an ear tap will be performed to help identify what kinds of germs are causing the ear infection.
What is an ear tap?
An ear tap is a medical procedure. Anesthesia (numbing medicine) is first placed in the ear, to reduce pain. Afterwards, the health care provider looks into the ear using an otoscope to confirm that it looks infected. A needle is inserted to “suck out” the infected fluid behind the ear drum. This fluid is sent to the lab for studies.
The ear tap itself may help relieve pain, since it releases pressure on the ear drum.
How does this help my child?
An ear infection causes pain because it produces pus that puts pressure behind the ear drum. An ear tap releases the pressure and relieves the pain instantly. It is also much easier to treat an infection once the pus is removed.
In past studies in RGH, children who got ear taps to help treat an ear infection have a much lower chance of having repeated ear infections. Fewer of them also needed surgery to get ear tubes placed. This is some of the data from RGH’s Ear Immunity Study from 2008 – 2016:
Because of the ear taps, the lab may also be able to find out what germs are causing the ear infection. This might help your provider choose better medicines to treat the infection. If the infection is caused by a virus, then no antibiotics would be needed. This is called individualized care or personalized medicine. This cannot be done without an ear tap.
What about my or my child's privacy?
Researchers understand concerns about medical information being stolen or misused. This is why only the doctors and nurses who take care of your child know of your child’s enrollment in the Study. These records are kept in your pediatrician’s office. The researchers need to know some medical information, but are only given a “study patient number.” They are never told your child’s name.
- Is a patient at a participating pediatric practice,
- Is healthy and between 6 and 12 months old, or,
- Between 6 and 36 months old and with an active ear infection