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

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).

Study Overview

• Status: Completed
• Conditions: Congenital Cytomegalovirus Infection

• Study Type: Observational
• Enrollment (Actual): 479

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Maternity Hospital CHRU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• No one

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modalities of realisation of screening test	Test by PCR in saliva and appropriate indications	baseline
Maternal CMV infection as a Risk Factor for Congenital CMV Infection	Association between Maternal infection and Neonatal CMV infection	baseline
Hypotrophy as a Risk Factor for Congenital CMV Infection	Association of a Neonatal weight below the 10th centile and Neonatal CMV infection	baseline
Microcephaly as a Risk Factor for Congenital CMV Infection	Association of a Neonatal head circumference below the 10th centile and Neonatal CMV infection	baseline
Any foetal ultrasound abnormality as a Risk Factor for Congenital CMV Infection	Association of any abnormality at fetal ultrasound examination and Neonatal CMV infection	baseline
Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection	Association of hepatomegaly or splenomegaly and Neonatal CMV infection	baseline
Any neurological abnormality as a Risk Factor for Congenital CMV Infection	Any neurological abnormality at clinical examination as a Risk Factor for Congenital CMV Infection	baseline
Any blood count cell abnormality as a Risk Factor for Congenital CMV Infection	Any blood count cell abnormality at biological check up as a Risk Factor for Congenital CMV Infection	baseline
Biological hepatic abnormality as a Risk Factor for Congenital CMV Infection	Any biological hepatic abnormality at biological check up as a Risk Factor for Congenital	baseline
Hearing abnormality as a Risk Factor for Congenital CMV Infection	Failure at hearing screening as a Risk Factor for Congenital CMV Infection	baseline
Hypotrophy as a consequence of diagnosed Congenital CMV Infection	Association of a birth weight below the 10th centile with a diagnosed Neonatal CMV infection	baseline
Microcephaly as a consequence of diagnosed Congenital CMV Infection	Association of a Neonatal head circumference below the 10th centile with a diagnosed Neonatal CMV infection	baseline
Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection	Association of an hepatomegaly or spenomegly with a diagnosed Neonatal CMV infection	Baseline
Any neurological abnormality as a consequence of Congenital CMV Infection	Association of a neurological abnormality at clinical examniation with a diagnosed Neonatal CMV infection	baseline
Any blood count cell abnormality as a consequence of Congenital CMV Infection	Association of any blood count cell abnormality with a diagnosed Neonatal CMV infection	baseline
Biological hepatic abnormality as a consequence of Congenital CMV Infection	Association of any biological hepatic abnormality with a diagnosed Neonatal CMV infection	baseline
Hearing abnormality as a consequence of Congenital CMV Infection	Association of failure at hearing screening with a diagnosed Neonatal CMV infection	baseline

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Herpesviridae Infections; Infections; Communicable Diseases; Cytomegalovirus Infections
• Other Study ID Numbers: 2022PI027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No