Ear Tube Research Study-2013

Does your child have ear tubes?

Are the ear tubes currently draining fluid?

Is your child healthy and ready to participate in a clinical research study?

He or she may qualify for a study that evaluates the effectiveness and safety of investigational ear drops when applied topically to a child’s ear.

Study Pre-Qualifications

To pre-qualify for this study, your child:

    • Must be 6 months to 12 years old
    • Must have Tube(s) in their ear(s)
    • Must be suffering from otorrhea (ear drainage) for three weeks or less, in an ear that has a tympanostomy tube in it (tympanostomy is otherwise known as an ear tube)
    • Must not have received any other treatment for this episode of otitis
    • Must not have any history of craniofacial anomalies
    • Must not have had any other otologic surgeries within the past year
    • Must be willing to participate in at least four study visits over the course of approximately 3 weeks

If your child qualifies for the study and you and your child wants to participate, you will be given an informed consent form to sign. The form will explain all the study procedures in detail. Please ask your study doctor questions and make sure that you understand all of the answers before you sign the consent form.

All Exams, Tests and Medications Provided at No Cost

If your child participates in the study, all study-related exams, hearing test and study medication are provided at no cost to you.

About the Ear Tube Drainage Research Study

The Ear, Nose and Throat Center is participating in a research study that is comparing safety and effectiveness of investigational, medicated eardrops against the other eardrops which are antibiotic alone or steroid alone. This study will include children from 6 months to 12 years of age who are experiencing moderate or severe ear fluid drainage in an ear with a tympanostomy tube.

The investigational, medicated eardrops combine antibiotic medication with a steroid, while the other eardrops are the antibiotic alone or steroid alone. This study will be conducted at about 70 different centers in the United States, Canada, Africa, and Europe.

Neither you nor your study doctor will know which treatment your child receives, but the doctor can get this information if necessary.

The study doctor will give your child the first dose of medication in the clinic, and will demonstrate how to give your child the remaining doses at home. You will be asked to give your child the study medication every 12 hours. You will also be asked to fill out a small booklet, called a diary card, every day while your child is in the study. In it you will record the time that you gave your child the study medication and answer some questions about how your child is doing in the study.

The doctor will also need to take some samples of the fluid in your child’s ear. This sample is taken using a small piece of tubing attached to a vacuum device, or in some cases using a syringe. The vacuum device may be noisy but it is not dangerous.

Once all the procedures are completed on the first day, your child will be randomly assigned to receive one of three treatments.

    • If your child is assigned to the study treatment, your child will receive drops containing both an antibiotic and a steroid.
    • If your child is not assigned to the study treatment, your child will receive drops containing either an antibiotic alone or a steroid alone.

Requirements During Study

We screen all participants in advance. If your child is accepted into the study, the child (and/or parent) must:

    • Keep all appointments. If you feel like your child cannot wait until the next study appointment to see the doctor, please call the doctor’s office right away.
    • Ensure the study medication is placed in the ear(s)
    • Complete all the information requested in the diary card until the end of the study. Your doctor uses the diary card to see how your child was doing on the days when he didn’t see the child in the office. If you are having trouble filling out the diary card, please ask your study doctor or nurse for help.

If you have any questions or concerns at any time, or if you forget how to give the medication, how to fill out the diary card, or when your appointments are scheduled, please call 801-328-2522. Our clinical trials staff and our ENT doctors are ready to answer questions.

Duration of Study

The study lasts approximately three weeks. There are at least four scheduled office visits during the 3-week study period. During the clinic visits, your child will undergo a series of medical tests and assessments to monitor safety and progress.

Clinical Cure Not Guaranteed

While we hope that your child’s infection will resolve on the medication he or she receives for the study, clinical cure cannot be guaranteed. If your child does not get better while taking the study medication, please tell your study doctor. The study doctor can take your child off the study medication and give him or her different medicine, including the medicine your child would receive if he or she were not participating in the study. It is important that you ask the study doctor before giving your child any other medication during the study period.

Your study doctor or nurse will give you a 24-hour telephone number to call if you have any questions or concerns while your child is participating in the study.

About Clinical Research Trials and Associated Risks

Choosing to participate in a clinical research trial is an important personal decision that you will make for your child. If your child is old enough to understand, you and your child will be asked to make the decision together.

There are risks to clinical trials as well as possible side effects to participation; however, every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB), to make sure the risks are as low as possible and that they are balanced with any potential benefits. An IRB/IEC is an independent committee of physicians, community advocates, and others who ensure that a clinical trial is ethical and that the rights of study participants are protected.

Read our article What is a Clinical Trial to learn more about how you can participate in clinical trials.

Protecting Study Participants and Withdrawal from Study

Your privacy is our priority. Researchers and study administrators must follow strict rules to protect the safety of study participants. Participation is voluntary and a participant may withdraw, or a parent/guardian may decide to withdraw their child from the study at any time, for any reason. We ask that any participants who withdraw notify the research coordinators, nurses or doctors of their decision to withdraw.

Contact Holly Featherstone with Questions

If you have questions about the investigational medication or about the study in general, please contact Holly Featherstone at 801-328-2522. She will be happy to answer your questions.

See: Current Ear, Nose and Throat Center Clinical Trials

Read: 5 Facts about Ear Tube Surgery

Read: ENT Doctor Answers 5 Questions about Ear Tube Surgery and Otis Media

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