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Project

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A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

Center:
AL-Civitan International Research Center, UCEDD/LEND
Fiscal Year:
2015
Contact Information:
Kristy Domnanovich
[email protected]
205-934-1106
Project Description:
A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) is being conducted by the Maternal-Fetal Medicine Units (MFMU) Network. Audiology and Psychology faculty at the UAB LEND are participating in this study. This study is a randomized double-masked placebo controlled multi-center clinical trial that will address the primary research question: does maternal administration of CMV hyperimmune globulin lower the rate of congenital CMV infection among the offspring of women who have been diagnosed with primary CMV infection during early pregnancy? Women with evidence of primary CMV infection before 23 weeks gestation will be randomized to one of two monthly treatments during pregnancy, active (Cytogam) or placebo (Albuminar and D5W). A key secondary outcome measure is sensorineural hearing loss (unilateral and bilateral) at 24 months. In addition, the cognitive and social/behavioral development of these children will also be assessed.
Keyword(s):
Core Function(s):
Demonstration Services
Area of Emphasis
Health-Related Activities
Target Audience:
Children/Adolescents with Disabilities/SHCN
Unserved or Under-served Populations:
Disadvantaged Circumstances
Primary Target Audience Geographic Descriptor:
National
Funding Source:
COVID-19 Related Data:
N/A
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