Randomized Controlled Trial of Valganciclovir for CMV-Infected Hearing Impaired Infants (ValEAR) Research Study
The University of Minnesota has agreed to take part in a clinical trial that will be conducted at many different centers throughout the United States. The study is run by the University of Utah and is funded by the National Institutes of Health (https://clinicaltrials.gov/ct2/show/NCT03107871?term=valear&rank=1).
Purpose
Congenital CMV affects one in 200 newborn infants in Minnesota. Although some infants have severe illness that is obvious at birth, this is rarely observed and probably happens in only ~10% of cases. More typically, there are no symptoms associated with congenital CMV. Asymptomatic babies can have isolated hearing loss at birth as the only manifestation of CMV. Infants with asymptomatic infection and normal hearing can go on to suffer CMV-associated hearing loss later in childhood. We know from other studies that an antiviral medicine, valganciclovir, can improve hearing outcomes in symptomatic babies. It would be helpful if we had a medicine that could improve the chance that hearing will stabilize or improve in asymptomatic babies with hearing loss as the only manifestation of illness. Currently, there is no knowledge about whether this medication can improve the outcome in these infants.
We are doing this study to compare the hearing and language outcomes of infants who receive 6 months of the investigational drug, valganciclovir, with children that do not receive valganciclovir but instead receive a placebo. We also want to learn about safety and if there are any side effects of giving valganciclovir to infants with hearing loss caused by CMV.
We hope to enroll 216 participants (108 parent/child pairs) in total from all centers involved in the study throughout the United States.
How to Participate in this Study?
You and your child can participate in this study if your child is less than or equal to 12 months of age, has been diagnosed with congenital CMV, and has hearing loss in one or both ears. Some additional testing will confirm that your child has no other symptoms of CMV-related illness, other than hearing loss.
If you agree to have your child participate, your child will be randomized (like tossing a coin) to receive placebo (sugar solution with no study drug) or valganciclovir by mouth for 6 months. Half of the babies in this study will receive valganciclovir and the other half will receive placebo.
After your child begins to take the study drug, it will be necessary for your child to have blood tests done. Blood tests are used to monitor your child’s health, the level of virus and drug in your child’s blood, and to monitor any abnormal results that might be caused by the study medication.
Once your child has received 6 months of either valganciclovir or placebo, we would like you to answer questions regarding your child’s language and development when he/she is 14 and 22 months of age via phone surveys.
Study Update
This study is a multi-center trial that has just started to enroll patients. Please go to https://valear.org/ for more information and study updates!
Study Contacts
Researcher Name: Dr. Mark R. Schleiss
Phone Number: 612-626-9913
Email Address: [email protected]
Study Staff: Emily Graupmann
Phone Number: 612-625-6421
Email Address: [email protected]