Diagnosing Congenital CMV Infection in Newborns as a Model for Universal Newborn Screening and Early Intervention
Purpose
The purpose of this research study is to evaluate the potential for expanding newborn screening in Minnesota to include testing for congenital CMV infection. The Minnesota Newborn Screening Program, coordinated by the Minnesota Department of Health, does not currently screen babies for congenital CMV. In fact, there is no state in the United States that includes congenital CMV in its testing program. This study is also evaluating which method of newborn screening – testing of a blood sample obtained on a filter paper card, or analysis of a saliva sample obtained with a swab – is the best technique for screening for congenital CMV. This study is being conducted through the University of Minnesota, in partnership with the Minnesota Department of Health (MDH) and is funded by The Centers for Disease Control and Prevention.
How to Participate in this Study?
Your child can participate in this research study if your baby is born at one of the following hospitals and is having routine newborn screening:
- University of Minnesota Masonic Children’s Hospital
- Fairview Southdale Hospital
- Fairview Ridges Hospital
- Allina Abbott Northwestern Hospital
- Allina United Hospital
If your baby is born at one of these hospitals, a research coordinator may approach you on the mother-baby floor (post-partum unit). If you agree to participate and sign a consent form, the research coordinator will collect a saliva sample from your child. The MDH will at a later date send some of your baby’s blood spot – collected as part of routine newborn screening – to laboratories at the University of Minnesota and the CDC for CMV testing. Your baby will not have to provide extra blood to take part in this study.
Benefits of Participation
A direct benefit of being in this study is that you and your baby’s doctor will be told the results of the CMV testing if your baby is found to have CMV. Additional medical evaluation is recommended for babies that are confirmed to have congenital CMV infection: this is not a part of the study, but a part of your child’s routine pediatric care. An indirect benefit of taking part in this research study will help the research team learn more about CMV screening for future children.
Study Update
Our goal is to enroll 30,000 babies! As of June 2019, we have enrolled >12,000 babies from the five hospitals.
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]