The National Institute of Allergy and Infectious Disease recently awarded the UAB Department of Pediatrics contracts totaling $11.5 million to support two studies that will assess treatment of babies born with congenital cytomegalovirus (CMV) without symptoms, and the frequency of neonatal herpes infections in the United States and Peru.
Almost one percent of babies born in the United States will have CMV, the largest nongenetic cause of sensory loss and mental disabilities. 90 percent of these babies will be asymptomatic at the time of birth. Early detection and close follow-up can lessen the effects of congenital CMV in infants. The new study will explore whether treating babies with four months of an oral drug -- valganciclovir -- that targets the virus can improve outcomes.
"Our team of researchers and physicians has been instrumental in learning more about CMV and treating the disease," said David Kimberlin, MD, who holds the Sergio Stagno, MD Endowed Chair in Pediatric Infectious Disease at UAB. "The next step is being able to identify and treat CMV in babies who are asymptomatic at birth."
In 2011, UAB researchers Suresh Boppana, MD and Karen Fowler, DrPH developed a saliva test that can identify the silent virus in newborns with 97 percent accuracy. This has directly led to increasing testing of babies for CMV.
"Now there is a targeted screening program for identifying CMV," said Kimberlin. "Under this new contract, we can build upon the previous studies to observe and identify proper treatment plans for the asymptomatic population of infants."
The five-year study across nine sites will look at male and female infants under one month of age with asymptomatic congenital CMV infection. Four months of oral valganciclovir, an antiviral treatment for infections caused by viruses, will be administered to babies without baseline sensorineural hearing loss. Those with baseline SNHL will also be enrolled if they are receiving oral valganciclovir prescribed by their physician.
A $1.5 million contract will support a study to assess the incidence of neonatal herpes infections in the United States and Peru using large databases in both countries to see how common the infection is. Knowledge gained from these investigations will inform future therapeutic studies aimed to decrease mother-to-infant transmission of herpes simplex virus. A prospective trial also will be conducted in Peru under this contract.