Abstract
Background
Human cytomegalovirus (HCMV) is the leading infectious cause of congenital disabilities. We designed a prospective study to investigate the rate, outcome and risk factors of congenital cytomegalovirus infection (cCMV) in neonates born to immune women, and the potential need and effectiveness of hygiene recommendations in this population.
Methods
The study (NCT03973359) was composed of 2 sequential parts: an epidemiology (Part 1) and a prevent ion (Part 2) study. Performance of Part 2 depended upon a cCMV rate > 0.4%. Women enrolled in Part 1 did not receive hygiene recommendations. Newborns were screened by HCMV DNA testing in saliva and cCMV was confirmed by urine testing.
Results
Saliva swabs were positive for HCMV DNA in 45/9661 newborns and cCMV was confirmed in 18 cases. The rate of cCMV was 0.19% (95% CI: 0.11-0.29%), and three out of 18 infants with cCMV had symptoms of CMV at birth. Age, nationality, occupation and contact with children were similar between mothers of infected and non-infected newborns. Twin pregnancy (OR: 7.2; 95% CI 1.7-32.2; p = 0.037) and maternal medical conditions (OR: 3.9; 95% CI: 1.5-10.1; p = 0.003) appeared associated with cCMV. Given the rate of cCMV lower than expected, the prevention part of the study was cancelled.
Conclusion
Newborns from women with preconception immunity have a low rate of cCMV, which appears to be mostly due to reactivation of the latent virus. Therefore, serological screening in childbearing age would be pivotal to identify HCMV-seropositive women, whose newborns have a low risk of cCMV.
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