ATOMIC Ears Study

Grommet surgery is a common form of treatment for young children suffering multiple ear infections. Up to a third of these children need repeat sets of grommets because the bacteria hides in “slime” in the middle ear called biofilm.

Biofilm protects the bacteria from the body’s immune response and prevents antibiotics from working properly, so researchers are investigating potential new treatments to prevent this from occurring.

We are looking for children to take part in the ATOMIC Ears Study and help evaluate  a new treatment designed to prevent ongoing ear infections in kids having grommet surgery.

What are grommets?

Grommets are tiny tubes inserted in the ear drum to drain fluid from the middle ear. Grommets are used to help treat children with recurrent middle ear infections and ‘glue ear’, and are the second most common reason for young children to undergo surgery.

How would the study treatment prevent ear infections?

In a previous study, researchers found that a medicine commonly used in cystic fibrosis treatment, Dornase alfa, has the ability to break down the biofilm in the ears of children with recurrent middle ear infections.

In the ATOMIC Ears Study, we hope to find out if using Dornase alfa ear drops during and after grommet surgery can help prevent further ear infections, potentially reducing the number of children requiring repeat grommet surgery.

What happens in the study?

Researchers will work closely with your child’s Ear, Nose and Throat (ENT) surgeon, who will collect samples during surgery including saliva, nasal swab, blood, middle ear fluid (if present) and adenoid tissue (if your child is having their adenoids
removed).

Your child will be randomly assigned with either a five-day course of Dornase alfa ear drops or placebo ear drops, and will remain under the care of their ENT surgeon for the duration of the study.

Participation will also involve visits to our clinic at the Perth Children’s Hospital over
a two-year period. These visits will include:

• An initial appointment to make sure that your child is eligible to take part in the study

• Regular ear check-ups, including hearing tests, reviewing the ear drum for any new infections and checking to see if the grommets are still working

• Three additional swabs of the inside of your child’s nose at two weeks, one year and two years after your child’s grommet surgery to tell us about what germs are present.

Involvement is voluntary and reasonable parking costs will be reimbursed for study
appointments at Perth Children’s Hospital.

Is it safe?

Dornase alfa is a licensed medication currently being used extensively in Australia as a treatment for cystic fibrosis in adults and children. It is inhaled into the lungs via a nebuliser to help thin and loosen mucous in the airways.

In the ATOMIC Ears Study, Dornase alfa will be given as ear drops, and these drops have already been provided to 60 children during grommet surgery in a previous study. This was found to be safe and well tolerated.

This study has been approved by the ethics committee of the Child and Adolescent Health Service.

Who can participate?

Children aged six months to five years who have a history of recurrent middle ear infections or glue ear, and are scheduled to undergo grommet surgery are invited to participate.

Please contact the ATOMIC Ears Study staff if you would like more information or to get involved.

Phone: 0400 450 240
Email: ATOMICEars@telethonkids.org.au