Prevalence, Outcome, and Prevention of Congenital Cytomegalovirus Infection in Neonates Born to Women With Preconception Immunity (CHILd Study)
Daniele Lilleri, Beatrice Tassis, Lorenza Pugni, Andrea Ronchi, Carlo Pietrasanta, Arsenio Spinillo, Alessia Arossa, Cristian Achille, Patrizia Vergani, Sara Ornaghi, Silvia Riboni, Paolo Ivo Cavoretto, Massimo Candiani, Gerarda Gaeta, Federico Prefumo, N. Fratelli, A. Fichera, M. Vignali, Allegra Barbasetti di Prun, Elisa Fabbri, Irene Cetin, Anna Locatelli, Sara Consonni, Simona Rutolo, Elena Miotto, Valeria Savasi, Maria Di Giminiani, Antonella Cromi, S. Binda, L Fiorina, Milena Furione, Gabriela Cassinelli, Catherine Klersy, for the CHILd Study Group, Stefania Piccini, Valentina Marrazzi, Giulia Muscettola, Paola Zelini, Piera d’Angelo, Marica De Cicco, Daniela Cirasola, Federica Zavaglio, Lea Testa, Claudia Ballerini, Rebecca Stachetti, Marta Ruggiero Fondazione, Federica de Liso, Annalisa Cavallero, Isadora Vaglio Tessitore, Maria Luisa Ventura, Mirko Pozzoni, Camilla Merlo, Giulia Rivetti, Vania Spinoni, Gaia Maria Belloni, Camilla Querzola, Marta Pessina, Elisa Ligato, Alice Zavatta, Marta Balconi, Serena Mussi, Patrizia Biraghi, S. Cammarata, Fabio Ghezzi, Massimo Agosti, Laura Pellegrinelli, Cristina Galli, V. Prímache
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 CMV (cCMV) infection in neonates born to immune women, and the potential need and effectiveness of hygiene recommendations in this population. METHODS: The study was composed of 2 sequential parts: an epidemiology (part 1) and a prevention (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 .19% (95% confidence interval [CI]: .11-.29%), and 3 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 noninfected newborns. Twin pregnancy (odds ratio [OR]: 7.2; 95% CI: 1.7-32.2; P = .037) and maternal medical conditions (OR: 3.9; 95% CI: 1.5-10.1; P = .003) appeared associated with cCMV. Given the rate of cCMV was lower than expected, the prevention part of the study was cancelled. CONCLUSIONS: 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. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov (NCT03973359).