2-Year Follow-Up: Does CMV Hyperimmune Globulin Improve Childhood Developmental Outcomes?
BACKGROUND AND PURPOSE:
A previous study identified no change in congenital cytomegalovirus (CMV) infection or fetal/neonatal death when pregnant women with primary CMV infection were treated with CMV hyperimmune globulin
Hughes et al. (NEJM, 2023) reported the results of a planned 2-year follow-up study involving the children of these mothers to evaluate whether CMV hyperimmune globulin improves childhood outcomes
2-year follow-up to multicenter, double-blind trial
Pregnant women with primary CMV infection
Follow-up focused on the offspring
Monthly infusion of CMV hyperimmune globulin during pregnancy until delivery (100 mg per kg of body weight)
Follow-up of children: Performed by certified research staff for 2 years
Participants and trial personnel blinded to treatment assignments
Definition of CMV infection with severe disability: Sensorineural hearing loss | Developmental delay | Chorioretinitis | Seizure disorder
Composite of death or CMV infection with severe disability
There was no difference between the groups in the risk of death or CMV infection with severe disability at 2 years
CMV hyperimmune globulin: 13.4% | Placebo: 10.1%
RR 1.33 (95% CI, 0.71 to 2.50)
There were no differences in any of the components of the composite outcome either
At 2 years, there was no benefit of CMV hyperimmune globulin treatment in pregnancy on developmental outcomes of children born to mothers with primary CMV infection
The authors state
These results, along with those previously reported, do not support the use of maternal CMV hyperimmune globulin to improve outcomes in the children of women with primary CMV infection in early pregnancy
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