What will my child and I have to do if we take part?

After you have looked at the trial information, and if you have no more questions and have decided you would like your child to take part in the trial, then you will be asked to read and sign a consent form to confirm this in writing.

You will be given a copy of the consent form and the information on this website to keep. Once you have signed the consent form, you will be asked some questions about your child’s respiratory health and we will check that the trial remains suitable for your child before starting treatment and following the trial plan.

Before your child’s treatment is dispensed and posted to your home, your local research team will collect some other information about them, including medical history, recent vaccinations, current medications and school attendance.

They will also ask you to complete some questionnaires and may measure your child’s weight and take a nasal swab. You will then go home and complete the sleep assessment(s). After this has been completed your child will start their treatment at home.   The treatment will be given once daily every Monday, Wednesday and Friday.

Your child will receive either 12 months of azithromycin or placebo.

During this time, your local research team will be in touch with you each month to ask how your child is getting on and if, for example, they have been to see their GP. Usually this will be by phone or email, however, every 3 months this will be face-to-face so you can be provided with more of your child’s treatment, asked to complete some questionnaires and provide a nasal swab. Your research team will try to make these face-to-face follow ups as easy as possible for you, for example, by arranging them at the same time as your normal clinic visits where possible.  If it is not possible for you to attend face-to-face hospital appointments, your research team will arrange follow-up through home visits or by video conferencing.  Your child’s treatment will be posted directly to your home.

At the 12-month follow up visit, your child will stop trial treatment and return to the standard treatment at their hospital.

There may be an additional face-to-face follow up visit at 20 months, which will follow a similar format as the other face-to-face follow up visits. Your research team will be able to tell you more about whether your child will take part in this additional visit.

Answering the questions and completing questionnaires will take about 15 minutes each time.

The questions include how your child is getting on and the questionnaires will ask about yours, and your child’s, sleep and quality of life.

Your local research team will weigh your child at the start and end of the trial or ask you to provide a recent weight if available.

In addition, if your child visits their hospital outside of the arranged follow up visits due to a chest infection your local research team will also collect some information about this visit and may take some nasal swabs.