Leiden CONCERT study 2.0
E1.3.1 Letter of participation in treatment but refusal of follow-up P13.168 / Version 1.0 / 30-07-201
Letter for CONCERT study 2.0
Participation in treatment research
Dear parents or carer,
Your child has been diagnosed with congenital CMV infection after testing the heel prick blood sample. You were informed of this outcome by telephone and recieved a letter about it.
At the Audiology Centre, your child was found to have hearing loss.
Participation in treatment research
You are receiving this letter and information folder to ask your consent to participate in the second part of the CONCERT study 2.0. With this national study, we are researching whether early treatment of children with a congenital CMV infection and hearing loss with a medicinal product can prevent worsening of the hearing.
A summary of the study
We are offering to treat all children with hearing loss and less than 13 weeks old shown to have a congenital CMV infection in the CONCERT study 2.0. After the treatment a follow-up hearing test and development test will be done of your son or daughter at the age of 1.5-2 years.
To evaluate the effect of the treatment. we carry out the same hearing test and development test on a group of children with congenital CMV infection and hearing loss who have not been treated. Because these children are now 1.5-2 years old, we call them a “historical” control group. It is also possible not to have your child treated if you don’t want to but still participate in the follow-up hearing test and development test.
Your child will then be included in the untreated “refusal” control group.
It is important to read the enclosed folder carefully before consenting to participate in this study.
If you wish to grant consent, please sign the informed consent form and post it using the enclosed envelope (stamp is not required). The treatment should start preferably at as young an age as possible, but definitely before the age of 13 weeks.
You can find full details about the CONCERT study 2.0 on the www.lumc.nl/concert website. For questions about this study, you may contact me at any time.
With kind regards, Fleurtje Schornagel
Also on behalf of the Leiden CONCERT study group
Direct dial: 071-526 5383 Secretariat: 071-526 3931 E-mail: f.a.j.schornagel@lumc.nl
