Recurrent Acute Otitis Media

Efficacy of Tympanostomy Tubes for Children with Recurrent Acute Otitis Media

Protocol Description

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. 

Ventilating Tubes

Antibiotics

- 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.

Benefits

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.

Eligibility Criteria

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.

Requirements

Part 1: Screening Phase

  • Enrollment visit between October 1 and March 31
  • Study team will examine children with cold symptoms within 48 hours of any symptom suggestive of an ear infection, when cold symptoms persist for at least 5 days, and every 2 months for 2 years. 
  • We will contact parents every 2 weeks to monitor their children for any new cold symptoms.
  • Children will be followed in the screening phase until they meet criteria for rAOM or for 12 months if they do not develop episodes of ear infections.

Part 2: Randomization Phase

  • There is a 50/50 chance that children will have ear tubes placed within 2 weeks or treated with oral antibiotics when he/she has an ear infection.
  • Study team will examine children with cold symptoms within 48 hours of any symptom suggestive of an ear infection, when cold symptoms persist for at least 5 days, and every 2 months for 2 years. 
  • When children have an ear infection, we will send parents an email to complete a symptom diary on Days 1 through 5 and at Day 12.
  • Children will have one final end-of-study visit 2 years after randomization.

Status: Open to Enrollment

Source(s) of Support

NIDCD, NIH

Primary Investigator

Alejandro Hoberman, MD

Contact Information

For more information or to register to learn more, visit
https://trialspark.com/#/trials/chpaomstudy
or call 412-999-EARS (3277)