Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk

NCT05754879 | Completed

• 1 other identifier: 2022PI027
• Study Type: observational
• Target: 479
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Relevance of the Protocol for defining a population at risk

  Comparison between Prevalence in the targeted population and Prevalence in the general Population

  baseline

Secondary Outcomes (17)

• Modalities of realisation of screening test

  baseline

• Maternal CMV infection as a Risk Factor for Congenital CMV Infection

  baseline

• Hypotrophy as a Risk Factor for Congenital CMV Infection

  baseline

• Microcephaly as a Risk Factor for Congenital CMV Infection

  baseline

• Any foetal ultrasound abnormality as a Risk Factor for Congenital CMV Infection

  baseline

Eligibility Criteria

• Age: Up to 3 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All NewBorn born between January 2019 and December 2021 who have had Screening Congenital Cytomegalovirus Infection by PCR in saliva

You may qualify if:

• Newborn born between Bebruary 2019 and December 2021 in the Regional Maternity Hospital of Nancy
• Patients who were screened for congenital CMV infection by salivary PCR

You may not qualify if:

• No one

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternity Hospital CHRU

Nancy, 54000, France

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 6, 2023
• Study Start: February 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-02

Locations

FR (1)