Congenital CMV Studies
Active Studies
Help advance our understanding of how the experiences of caring for a child with cCMV impacts families by completing up to 3 online questionnaires. This research study is open to caregivers, children with cCMV, and siblings. This paid research study is sponsored by RTI and Moderna. Learn more here.
With the goal of improving infant outcomes by creating disease specific guidance, interventions and support systems , the CUBS study is studying the developmental trajectories of infants with cCMV , their relationship with maternal stress, wellbeing and parenting experiences. Parents will complete PediaTrac, as well as the Little Ears surveys at five timepoints the first year of an infant ’ s life. The surveys track parent reported development and milestone achievement s . Remote participation enables the inclusion of parents across the US and Canada. Dr. Megan Pesch is the principal investigator on this NIH funded study.
Please contact Megan Thompson at cmvbabiesstudy@umich.edu for more information.
CMV Mothers’Beliefs, Experiences,And Relationships Study – Mama Bear Study
Researchers at the University of Michigan would like to learn more abou t the experience of bi ological mother s whose children have been diagnosed with cCMV. Mothers with children between ages 3 and 15 will complete a short survey prior to a zoom interview with a representative from ISR . The s emi - structure d interviews will discuss the experience with the diagnostic process and opportunities for intervention and treatment after the diagnosis of cCMV . Funding from the Congenital and Perinatal Infections Consortium (CPIC) makes this remote ly administered study possible.
More information is available at https://UMHealthResearch.org/studies/HUM00259824 or email cmvmamabearstudy@umich.edu
This is a Phase I study to determine the dose of oral letermovir to administer to neonates. Once we know this, we will develop a combination therapy study assessing the clinical benefit of oral valganciclovir + letermovir on clinically relevant disease outcomes such as hearing and development.
Merck Sharp & Dohme Corp, is actively recruiting and enrolling healthy, seronegative women ages 16-35 in multiple cities and locations to participate in this phase 2 vaccine study! The primary hypothesis of the study is that administration of a 3-dose regimen (day 1, month 2, and month 6) of V160 will reduce the incidence of primary CMV infection compared to placebo. Please direct questions to your local clinic or healthcare provider for more information.
Past Studies
The primary goal of this NIH funded multi-institutional study, spearheaded by principal investigator Dr. Albert Park, will be to determine whether CMV–infected hearing impaired only infants, treated with the antiviral drug valganciclovir, will have better hearing and language outcomes compared to untreated CMV-infected hearing impaired infants. Currently, the standard of care is to not treat these infants with valganciclovir since there was no previous efficacy and safety clinical trial data. We will also evaluate the safety of this drug, evaluate drug levels, viral levels and resistance in all enrollees.
The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies, with Cytogam - a Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), will reduce the number of babies infected with CMV. The research study is funded by the Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD) and 14 medical centers across the country are actively recruiting participants. A French study sought to determine the efficacy of CMV education counseling for pregnant women. The three-year CMV study tested pregnant women for CMV towards the end of their first trimester then followed with prevention education to those women who had never been exposed to CMV. Results found that fewer women went on to acquire CMV during pregnancy after adopting the recommended prevention measures.
A University of Alabama at Birmingham study found that an inexpensive polymerase chain-reaction (PCR)-based saliva swab test could help identify newborns with congenital CMV, who are at risk for developing hearing loss during childhood. Researchers report that this PCR test, costing only $2.50 to $3 per test, showed high sensitivity and specificity, identifying infected newborns with greater than 97 percent accuracy.
This randomized, placebo-controlled trial of valganciclovir found that extending treatment of infants born symptomatic with congenital CMV from the traditional six weeks to six months helped to improve hearing and developmental outcomes. The CMV study end points included change in hearing in the better ear (“best-ear” hearing) from baseline to 6 months as well as change in hearing from baseline to follow-up at 12 and 24 months.
Hearing Loss Treatment Study