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To evaluate whether CMV hyperimmune globulin (HIG) administered to women with primary CMV during pregnancy reduces adverse childhood outcomes at age 2 years.
Multicenter randomized double-masked trial of women with a singleton gestation < 24 weeks with primary maternal CMV infection defined by the presence of either CMV IgM and IgG with low avidity, or IgG seroconversion, as assessed by a central reference laboratory, without evidence of fetal infection. Monthly infusions of CMV HIG (100 units/kilogram) or placebo were given until delivery. At the time of delivery, congenital CMV infection or death did not differ between the HIG and placebo groups (22.7% vs. 19.4%). The primary composite 2-year child outcome included: death, sensorineural hearing loss (unilateral and bilateral), chorioretinitis, seizure disorder, or developmental delay (defined as cognitive score < 70 or motor score < 70 on the Bayley III).
At 17 centers from 2012 to 2018, 206,111 pregnant women were screened; 712 had primary CMV infection (0.35%), of whom 399 (56%) were enrolled and 78 infants (19.5%) had congenital CMV. 90% of children had data collected for the 24-month visit and 75% had complete 2-year outcomes available. The rate of the child primary composite outcome in the CMV HIG group was 13.4% compared with 10.1% in the placebo group (Relative Risk 1.3; 95% confidence interval (0.7, 2.5)). The proportion of children with CMV infection and severe disability was similar between the groups (4.1% vs. 4.7%, p=0.69) and there was no improvement in neurodevelopmental outcomes or in the percentage of children whose weight was < 10th percentile at 2 years (Table).
CMV HIG did not decrease adverse two year outcomes among children born to women with primary CMV infection in early pregnancy.