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

This correspondence reports the 2-year outcomes of a multicenter randomized controlled trial involving 399 pregnant women with primary CMV infection. Children were followed post-delivery to assess whether maternal CMV hyperimmune globulin improved health outcomes. At 24 months, data from 360 children showed no significant benefit in reducing severe disabilities including sensorineural hearing loss, developmental delay, seizures or death compared to placebo. The trial concludes that maternal hyperimmune globulin does not improve developmental or auditory outcomes for children with congenital CMV exposure.

This correspondence reports the 2-year outcomes of a multicenter randomized controlled trial involving 399 pregnant women with primary CMV infection. Children were followed post-delivery to assess whether maternal CMV hyperimmune globulin improved health outcomes. At 24 months, data from 360 children showed no significant benefit in reducing severe disabilities including sensorineural hearing loss, developmental delay, seizures or death compared to placebo. The trial concludes that maternal hyperimmune globulin does not improve developmental or auditory outcomes for children with congenital CMV exposure.