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

This 2 year follow up of a multicenter randomized trial evaluated the efficacy of CMV hyperimmune globulin (Cytogam) in improving outcomes for children born to mothers with primary CMV infection during pregnancy. Among 360 children (90% of original cohort), no significant difference was observed between the hyperimmune globulin and placebo groups in the composite outcome of death or severe disability (13.4% vs. 10.1%; relative risk 1.33, 95% CI 0.71–2.50). Severe disability included sensorineural hearing loss (1.4% vs. 4.8%), developmental delay (Bayley-III cognitive score <70: 2.6% vs. 2.5%), or other neurologic sequelae. The study, limited by low event rates and missing data, aligns with prior findings that maternal CMV hyperimmune globulin does not improve long-term pediatric outcomes, supporting discontinuation of its use for this indication.

This 2 year follow up of a multicenter randomized trial evaluated the efficacy of CMV hyperimmune globulin (Cytogam) in improving outcomes for children born to mothers with primary CMV infection during pregnancy. Among 360 children (90% of original cohort), no significant difference was observed between the hyperimmune globulin and placebo groups in the composite outcome of death or severe disability (13.4% vs. 10.1%; relative risk 1.33, 95% CI 0.71–2.50). Severe disability included sensorineural hearing loss (1.4% vs. 4.8%), developmental delay (Bayley-III cognitive score <70: 2.6% vs. 2.5%), or other neurologic sequelae. The study, limited by low event rates and missing data, aligns with prior findings that maternal CMV hyperimmune globulin does not improve long-term pediatric outcomes, supporting discontinuation of its use for this indication.