Randomized Trial of Hyperimmune Globulin for Congenital CMV Infection - 2-Year Outcomes

Brown University, Providence, RI brenna.hughes@duke.edu. George Washington University, Washington, DC. Brown University, Providence, RI. University of Texas Medical Branch, Galveston, TX. Northwestern University, Chicago, IL. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD. University of Alabama at Birmingham, Birmingham, AL. Columbia University, New York, NY. University of Utah Health Sciences Center, Salt Lake City, UT. University of North Carolina at Chapel Hill, Chapel Hill, NC. Ohio State University, Columbus, OH. Duke University, Durham, NC. University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO. Case Western Reserve University, Cleveland, OH. University of Texas Health Science Center at Houston, Houston, TX. Stanford University, Stanford, CA. University of Texas Southwestern Medical Center, Dallas, TX. University of Pennsylvania, Philadelphia, PA. University of Pittsburgh, Pittsburgh, PA. Madigan Army Medical Center, Joint Base Lewis-McChord, WA. Washington University, Saint Louis, MO.

The New England journal of medicine. 2023;389(19):1822-1824
PICO Summary


Pregnant women with primary maternal cytomegalovirus (CMV) infection (n= 399).


Monthly infusions of CMV hyperimmune globulin until delivery (n= 206).


Placebo (n= 193).


This planned 2-year follow-up study involved the children of the enrolled women to evaluate whether CMV hyperimmune globulin improves childhood outcomes. Partial data on 2-year outcomes were available for 360 children (90%). Death or CMV infection with severe disability occurred in 20 of the 149 children (13.4%) in the hyperimmune globulin group and in 15 of the 149 children (10.1%) in the placebo group (relative risk, 1.33; 95% confidence interval [0.71, 2.50]. No material differences were found between the groups in the incidence of any component of the composite outcome or in any other outcome at 24 months, including severe disability with or without congenital CMV infection. No deaths occurred after the delivery hospitalization.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine