Collaborative Grant to Study Integrated Newborn Screening Hearing and CMV Screening in MN


MarkSchleissBy Mark R. Schleiss, MD, Division Director, Pediatric Infectious Diseases and Immunology, U of M Medical School

A new grant has enabled establishment of a research partnership between Children’s Hospitals and Clinics of Minnesota and the University of Minnesota Medical Center (UMMC), aimed at evaluation of newborn infants who fail newborn hearing screening for possible congenital infection with cytomegalovirus (CMV).

CMV is the most common cause of congenital infection in pediatric practice, and is responsible for up to 30 percent of all cases of hearing loss in childhood. Although CMV can cause severe, clinically evident injury in newborns, consisting of features such as hepatosplenomegaly, microcephaly, and rash, most infants with congenital infection are in fact asymptomatic. Approximately 10-15 percent of asymptomatic congenitally infected infants will have hearing loss due to CMV infection.

All parents of children born in newborn nurseries at Allina Health and UMMC who receive a “refer” following newborn hearing screening will be offered the opportunity to participate in the study, which will consist of obtaining a saliva sample and urine sample from their newborn infant prior to discharge. Samples will be tested by PCR analysis for CMV viral DNA.

This point-of-care testing approach is important because if CMV testing is obtained for infants after 21 days of age, results can be confusing since many infants will acquire CMV after birth, most commonly from breastfeeding. A positive CMV test in a hearing-impaired infant beyond this age is therefore often impossible to interpret, since postnatal acquisition of CMV does not lead to hearing loss in normal newborns. Thus, this approach to testing will lead to great diagnostic certainty, and help identify some infants who may benefit from antiviral treatment with the anti-CMV agent, Ganciclovir, which has been shown to improve audiological and neurodevelopmental outcomes for some infants with congenital CMV infection.

Enrollment of infants began in July, 2015, and the proposed study period will be a minimum of one year. Additional funding opportunities (such as the National Institutes of Health, March of Dimes Birth Defects Foundation, and Centers for Disease Control) will hopefully extend the period of targeted screening and expand screening to other newborn nurseries in Minnesota.

Funded by Children’s Hospitals and Clinics of Minnesota’s Internal Research Grant Program (IRGP), study will represent a collaboration between the Division of Infectious Diseases at UMN, and co-PI Dr. Timothy Lander of the Children’s Hospitals and Clinics ENT and Facial Plastic Surgery group.

The study also comes at a time when many states are considering legislation that establishes newborn CMV testing for infants who do not pass hearing screening. Indeed, the governor of Utah in 2014 signed House Bill 81, the Cytomegalovirus Public Health Initiative. This bill, which can be read in its entirety at, had three key components:
1. It directs the Department of Health to create a public education program to inform pregnant women and women who may become pregnant about CMV and its transmission, fetal effects of CMV, methods of CMV diagnosis and prevention.
2. It requires the Department of Health to provide this information to licensed childcare programs, school nurses, health educators, and other organizations offering children’s programs as a component of worship services.
3. It directs medical practitioners to test infants who fail two newborn hearing screening tests for CMV before three weeks of age and inform the parents of those infants about the possible complications that CMV can cause and the available treatment methods.

Since passage of this bill, several other state legislatures have considered similar proposals, including Connecticut, Texas, and Illinois.

The major goals of this new research initiative will be to optimize methods of newborn screening for infants with failed hearing screens, and to characterize the epidemiology of congenital CMV in Minnesota newborns. Other questions to be examined by this project will include parental acceptance of CMV screening, and the diagnostic sensitivity of saliva-based screening.

For more information interested individuals can call 612-624-1112 (UMN Medical School, Division of Pediatric Infectious Diseases) or 612-874-1292 (Children’s Hospitals and Clinics of Minnesota, ENT Department).

Annual Sponsors

Children's Minnesota
Gillette Children's
Hennepin Healthcare
University of Minnesota Health
Essentia Health
Mayo Clinic
Shriners Healthcare for Children-Twin Cities