Leiden CONCERT study 2.0
E1.1 CMV diagnostics
P13.168 / Version 2.0 / 5-09-2013
Letter for CONCERT study 2.0
Research into congenital CMV infection
Dear parents or carer,
Your son or daughter is going to the Audiology Centre for additional hearing tests because earlier hearing tests produced an inadequate result. This letter is to inform you about the CONCERT study 2.0. You received this letter from the regional coordinator who conducted the third hearing test or from the audiologist at the Audiology Centre.
We are asking you to participate in a national study of children with actual or suspected hearing loss and a congenital virus infection. In this study, the CONCERT study 2.0, we are examining whether early treatment of these children can prevent the deterioration of their hearing. The study is being performed in the Leiden University Medical Center.
A virus infection as the cause of hearing loss.
There are several causes of hearing loss in children. A congenital virus infection (infection occurred in the womb) with cytomegalovirus (CMV) can cause hearing loss. This hearing loss is often evident immediately after birth, but can also develop later. The hearing loss can change over the course of the first few years of life, getting either better or worse.
Congenital CMV infection
Congenital CMV infection occurs rarely in the Netherlands, in 5 of 1000 newborn babies. It is more common in children with hearing loss. A quarter of children aged 5 years with severe hearing loss in both ears are demonstrably infected. Congenital CMV infection can be demonstrated in a test performed shortly after birth on a heel prick blood sample.
What are we asking of you?
At this moment, we are asking your permission to test the heel prick blood of your son or daughter for congenital CMV infection.
Benefits and disadvantages for you and your child Benefits:
There are no risks or costs associated with testing for congenital CMV infection. Because we make use of the heel prick blood sample taken shortly after birth, no new blood sampling is required. By participating in this study, you will learn whether your child has a congenital CMV infection or not. If your child has a congenital CMV infection, you can participate in the second part of the study. In the second part, your child can undergo treatment. In the second part of the study, a follow-up hearing test will be done and a test of your child’s development at the age of around 20 months. Neither participation in the second part of the study nor undergoing treatment is mandatory. Your child can participate in the hearing test and development test even if s/he does not undergo treatment. You will receive more information about the second part of the study if your child proves to have a congenital infection with cytomegalovirus.
Disadvantages:
You may become worried if you learn that your child has a congenital CMV infection. You may
Leiden CONCERT study 2.0
E1.1 CMV diagnostics
P13.168 / Version 2.0 / 5-09-2013
experience the additional testing (hearing and development tests) as a burden. These tests are only done if your child has a congenital CMV infection and will participate in the second part of the study.
What do we expect from you?
- If you decide to take part:
If you are willing to allow us to test your child’s heel prick blood sample, please complete and sign the enclosed informed consent form. Return the form within 2 weeks in the enclosed reply envelope (stamp is not required).
- If you decide not to participate:
Participation in the study is voluntary. If you decide not to take part, you do not need to do anything further.
What happens next?
With your consent, your child’s heel prick blood sample will be identified and tested for congenital CMV infection. No new blood sampling has to be done on your child. It takes about 3 weeks to test the blood after we receive your consent.
- If your child does not have a congenital CMV infection
If your child does not have a congenital CMV infection, you will receive a letter stating this outcome at home. Your family physician, the Audiology Centre, the well-baby clinic doctor and any involved ENT specialist or paediatrician will also be sent a letter.
- If your child has a congenital CMV infection
If your child has a congenital CMV infection, the investigator will call you to inform you of the result.
You will receive more information about the infection and the follow-up study and possible treatment.
Your family physician, the Audiology Centre, the well-baby clinic doctor and any involved ENT specialist or paediatrician will be sent a letter.
It is up to you whether you participate in the second part of the study or not.
What does the second part of the study involve?
There is a medicinal product available against CMV. It is not yet clear whether treating newborn babies with congenital CMV infection and hearing loss with this medicinal product will help to stop worsening of the hearing loss. That is why we are conducting this study. We shall compare a group of children receiving this treatment with a group that was not treated in the past.
If your son or daughter has a congenital CMV infection and hearing loss, and s/he is less than 13 weeks old, s/he can participate in the treatment trial. Your child will be given the medicinal product against CMV for 6 weeks. The medicinal product is liquid and taken orally. This treatment can be done at home. When s/he is 1.5 to 2 years old, an additional hearing test and development test will be done. These tests can also be done at home.
What happens to your data?
The data we collect are stored in a safe location and only examined by the study team. According to the law, we have to archive the data collected from this study for 15 years. The heel prick blood sample will also be stored for 15 years, with your consent.
Leiden CONCERT study 2.0
E1.1 CMV diagnostics
P13.168 / Version 2.0 / 5-09-2013
Do you have any questions?
If you would like to know more about cytomegalovirus, consult the www.lumc.nl/concert website or contact the investigator.
Many thanks for your cooperation in advance!
