Longitudinal Assessment of Asymptomatic Congenital CMV Infection in Minnesota Infants Identified by Universal Screening: What is Risk of Sequelae?
Purpose
The purpose of this research study is to learn more about asymptomatic and mild congenital CMV infection in infants. Asymptomatic infections refer to situations in which an infant does not show any signs that they have the infection. This includes either signs from a physical examination, or abnormal values on blood tests. Mildly symptomatic congenital CMV infection refers to situations when an infant shows one or two mild signs of infection. A separate category is infants with asymptomatic infection who have hearing loss as the only manifestation of infection. We know that the majority of infants who have congenital CMV are asymptomatic. However, all babies with congenital CMV, regardless of disease category, should have neurodevelopmental and audiologic follow-up.
We hope to learn more about the potential effects that congenital CMV may have on infant brain development. This study will also use urine samples to try to learn more about the CMV virus. The information we learn will be used to advocate for CMV screening as part of the routine newborn screening panel recommended for all newborns.
We hope to include 75 children with asymptomatic or mild CMV, and 30 children without CMV.
How to Participate in this Study?
You can participate in this study if:
- Your child was born with CMV and has no symptoms or only mild symptoms of congenital CMV;
- You child was diagnosed with congenital CMV through the Newborn screening program OR;
- Your child was referred to see an infectious disease doctor at the University of Minnesota for congenital CMV infection.
If you agree for your child to participate in this research, we would like to see your child at the University of Minnesota at different times during your child’s first two years following birth. As part of this study we would like to collect urine samples, and perform MRI scans of your child’s brain at two different times. Your child will also undergo neurodevelopmental testing at two different times.
MRI
If your child is a part of this research study, we would like to do an MRI scan of their brain at approximately 12 and 24 months of age. The MRIs for this study take place at the Center for Magnetic Resonance Research (CMRR) on the East Bank campus of the University of Minnesota. An MRI is a scan that uses a large magnet and radio waves to create detailed pictures of body tissues. The MRI for this study will scan your child during their natural sleep and it involves lying motionless in the scanning machine for about an hour. A researcher will monitor your child at all times and will stay with your child during the entire scan.
CMRR Contact
Study staff: Monica Bondy, Research Coordinator
Email: [email protected]
Office: 651-235-9083
Center for Magnetic Resonance Research
2021 6th Street S.E.
Minneapolis, MN 55455
612-626-2001
Neurodevelopment Session
If your child is a part of this research study, we would like to evaluate neurodevelopment by performing two assessments at approximately 12 and 24 months of age. The neurodevelopmental sessions take place at the Center for NeuroBehavioral Development (CNBD). There are three different assessments during this session:
- Event-Related Brain Potentials (ERP) - This assessment is a non-invasive way to look at brain activity, which involves placing a net on your infant’s head as he or she listens to sounds to record brain activity.
- Short Delayed Response Game - this test involves observing your child while a researcher hides a toy under a box within your baby’s reach, and your baby is allowed to search for and find the toy.
- Mullen Scales of Early Learning - this is a routine test used in infants and preschoolers, that uses various activities to understand their development, motor skills, and language.
CNBD Contact
Study staff: Kristin Sandness, Principal Lab Technician, Study Coordinator
Email: [email protected]
Office: 612-624-5665
Center for Neurobehavioral Development
717 Delaware Street S.E.
Minneapolis, MN 55414
Benefits of Participation
Benefits of this study include helping the research team to learn more about children with asymptomatic and mildly symptomatic congenital CMV, and the information we learn will help us advocate for CMV screening as a part of the newborn screening for all infants.
Study Update
June, 2019: We have enrolled 30 children without CMV, and 19 children with asymptomatic or mildly symptomatic CMV. All 30 children without CMV have had their first neurodevelopmental session, and 17 have completed their 2 year follow up neurodevelopmental session. Out of the children with CMV, 5 have had their first MRI scan and neurodevelopmental testing performed. We’re very grateful for each family’s commitment to the study!
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]