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. 2023 Feb 8;76(3):513-520.
doi: 10.1093/cid/ciac482.

Prevalence, Outcome, and Prevention of Congenital Cytomegalovirus Infection in Neonates Born to Women With Preconception Immunity (CHILd Study)

Daniele Lilleri  1 , Beatrice Tassis  2 , Lorenza Pugni  2 , Andrea Ronchi  2 , Carlo Pietrasanta  2   3 , Arsenio Spinillo  4 , Alessia Arossa  4 , Cristian Achille  5 , Patrizia Vergani  6 , Sara Ornaghi  6 , Silvia Riboni  6 , Paolo Cavoretto  7 , Massimo Candiani  7 , Gerarda Gaeta  7 , Federico Prefumo  8 , Nicola Fratelli  8 , Anna Fichera  8 , Michele Vignali  9   10 , Allegra Barbasetti Di Prun  9   10 , Elisa Fabbri  11 , Irene Cetin  11 , Anna Locatelli  12 , Sara Consonni  12 , Simona Rutolo  13 , Elena Miotto  13 , Valeria Savasi  14   15 , Maria Di Giminiani  14   15 , Antonella Cromi  16 , Sandro Binda  10 , Loretta Fiorina  1 , Milena Furione  1 , Gabriela Cassinelli  1 , Catherine Klersy  17 ; CHILd Study Group
Collaborators, Affiliations

Prevalence, Outcome, and Prevention of Congenital Cytomegalovirus Infection in Neonates Born to Women With Preconception Immunity (CHILd Study)

Daniele Lilleri et al. Clin Infect Dis. .

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).

Keywords: congenital infection; human cytomegalovirus; nonprimary infection; preconception immunity.

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Conflict of interest statement

Potential conflicts of interest. The authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Study population and rates of cCMV infection. Abbreviations: cCMV, congenital cytomegalovirus; eCRF, electronic Case Report Form.
Figure 2.
Figure 2.
HCMV DNA levels in saliva swabs of infected or uninfected (positive in saliva but negative in urine) newborns with HCMV DNA positive saliva swab at birth. Mann-Whitney U test was used for statistical analysis. Abbreviation: HCMV, human cytomegalovirus.
See this image and copyright information in PMC

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