NCT05754879

Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk

Congenital Cytomegalovirus Infection by Detection of the Virus in the Saliva of Newborns at Particular Risk: A Retrospective Population-based Study Between February 2019 and December 2021 at the Regional Maternity Hospital of Nancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 479 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 3 Weeks
• Healthy volunteers: Not accepted

Summary

Congenital CMV infection is the leading cause of non-genetic deafness and neurodevelopmental disorders. Its prevalence in France is estimated between 0.3% and 1% of births depending on the study. Congenital infection is symptomatic in 10% of cases with a large clinical spectrum with different degree of severity. These sequelae develop progressively and fluctuate, which justifies prolonged follow-up of children for several years, even if they are asymptomatic at birth. There is yet no treatment with AMM in neonates or pregnant women. In France, screening for congenital CMV infection is widely debated. It remains oriented to certain newborns considered at risk or depending on their symptoms and varies with the practices of each Neonatology or Maternity Hospital. In the Regional Maternity of Nancy, a new screening protocol for congenital CMV infection was implemented from early 2019. It is based on screening by non-invasive salivary test (CMV PCR) in newborns at particular risk who are included in a registry open for this screening. The aim of this research was to assess the relevance of the proposed criteria in the Protocol for defining a population at risk of congenital CMV infection thus qualifying for CMV screening. The secondary endpoints are the modalities of the screening test, the evaluation of each risk factor for infection, and the study of affected patients (symptoms, therapeutic intervention, neurological and auditory outcome).

Conditions

• Congenital Cytomegalovirus Infection

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2023-03-06
• Last updated: 2023-03-06

Locations

1 site across 1 country: France