Description
This is a randomized double-masked placebo-controlled multi-center clinical trial of women with evidence of primary CMV infection before 34 weeks gestation. Participants will be randomized to one of two monthly treatments: IV infusion of either CMV hyperimmune globulin or placebo. Before each infusion, additional blood and urine specimens will be collected to be stored for future studies or for viral load testing. The infants born to participants in this research study will be followed for 2 years, with visits scheduled at 12 and 24 months to test for CMV infection. Developmental testing will also be conducted at these visits. A hearing test will be done on the participants child at the 2 year visit.
Eligibility
Inclusion Criteria
o Diagnosis of primary maternal CMV infection
o Gestational age at randomization no later than 23 weeks
o Singleton pregnancy
o Must commit to 2-year follow up of the infant