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This study, funded by the National Institutes of Health (NIH), will help determine whether children ages 6 to 35 months diagnosed with recurrent ear infections (rAOM) (3 infections in 6 months or 4 in 12 months, with at least 1 episode in the past 6 months) need to have ventilating tubes placed in the ear drum or whether they can be effectively treated with antibiotics for each ear infection. There are pros and cons of each of these two treatment modalities.
- May reduce by 1 or 1.5 the average number of ear infections each year
- Are given with each ear infections: twice a day for 10 days
- Parents will see pus in the ear canal when their child has an infection
- Parents will know their child has an ear infection by the usual symptoms
- In most instances we will treat ear infections with antibiotic ear drops instead of antibiotics by mouth, thus decreasing the likelihood that germs that cause the ear infection to become resistant
- May increase the likelihood of germs becoming resistant and not being killed by the antibiotic
- The surgical procedure requires anesthesia which is generally not recommended in children under 3 years of age
- May have side effects such as allergy, diarrhea or a yeast infection.
- May become blocked, fall out of place (behind the ear drum into the middle ear or outside) or leave scars or persistent perforations of the ear drum
There are 2 phases to this program, a screening phase and a randomization phase. During the screening phase, we will identify a group of children who are at risk for recurrent ear infections, follow them over time and have our team of experts examine his/her ears to confirm that your child had at least 1 ear infection that we have seen. Children who actually go on to have rAOM will be offered to participate in the second part of the study, in which we will try to determine which children are most likely to benefit from ear tubes, and will be carefully followed for 2 years.
Children enrolled in our program will have careful monitoring and follow-up for ear infections. There will be no charges for visits. The clinical team is available by phone, 24 hours a day, and will see study participants whenever you have concerns that your child may have another ear infection.
Study participants also have the option of accessing information about the study at https://trialspark.com/#/trials/chpaomstudy.
Part 1: In the screening phase, we will obtain informed consent from the parent(s) of children who have risk factor(s) for recurrent ear infections, and follow them prospectively.
Part 2: In the randomization phase, children aged 6 to 35 months who meet inclusion criteria for rAOM will be randomized to have ventilating tubes which will be placed within 2 weeks or treated with oral antibiotics for future ear infections and have tubes placed later on if they continue to have recurrent ear infections.
Part 1: Screening Phase
Part 2: Randomization Phase
Alejandro Hoberman, MD
For more information or to register to learn more, visit https://trialspark.com/#/trials/chpaomstudy or call 412-999-EARS (3277)
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
Children’s Hospital of Pittsburgh of UPMC
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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