Studies Open for Enrollment

The Natural History of Cytomegalovirus (CMV) - Related Hearing Loss and the Feasibility of CMV Screening as Adjunct to Hearing Screening in Newborns

The study involves an initial screening at birth and a follow-up component to review how the congenital Cytomegalovirus (CMV) infection affects infants and its relationship to childhood hearing loss. CMV is the leading cause of congenital infection — that is infection of the baby while it is still in the mother’s womb. CMV is passed from mother to unborn child in about 1% of all pregnancies. Although most babies with congenital CMV infection do not have any problems due to the virus, around 15-20% will have hearing loss, visual problems, physical or developmental disabilities. The hearing loss due to congenital CMV infection can be present at birth or can develop later during childhood. The study will follow children with congenital CMV infection in a special clinic, which will provide examinations for early detection of any hearing loss.

This is an observational study and does not involve any treatment. Seven centers across the country are participating, screening 100,000 newborns with 1,000 participants in the follow-up study.

Candidates
All newborns at Magee Women’s Hospital in Pittsburgh are eligible to participate in newborn screening. Those that test positive for CMV are eligible to participate in the follow-up study at Children’s Hospital of Pittsburgh.

The goal is to screen up to 21,000 babies with approximately 144 children included in the follow-up study.
Boys: Newborns
Girls: Newborns

Requirements
Collection of saliva and blood samples from participating newborns is required for CMV screening. (The blood sample will be collected when the baby has other required newborn blood tests, so additional sampling for this screening will not be necessary.)

Participants in the follow-up study will make an initial clinic visit between 2 and 6 weeks of age. Additional clinic visits will be made at the following ages: 7 months, 12 months, 18 months, 24 months, 30 months, 3 years, 3½ to 4 years. A medical examination of each participant will take place at the initial clinic visit, as well as the collection of urine, saliva and blood samples. Medical examinations may also be conducted at other visits, if there is a need, and saliva samples will be collected at all follow-up visits. A hearing test will be conducted at each clinic visit.
Visits: 8, if included in follow-up study
Duration: 3-1/2 to 4 years.

Status: Open for Enrollment

How to Participate
To get started, please contact:
Cheryl Rosenberg, LPN, CCRC
412-692-7351

Additional Resources
Cytomegalovirus (CMV)

Principal Investigator
Marian G. Michaels, MD, MPH
Infectious Diseases

Source of Support
National Institute on Deafness and Other Communication Disorders