Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk

Congenital Cytomegalovirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05754879
• Other study ID #: 2022PI027
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Congenital Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infections

Locations

Country	Name	City	State
France	Maternity Hospital CHRU	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Modalities of realisation of screening test	Test by PCR in saliva and appropriate indications	baseline
Secondary	Maternal CMV infection as a Risk Factor for Congenital CMV Infection	Association between Maternal infection and Neonatal CMV infection	baseline
Secondary	Hypotrophy as a Risk Factor for Congenital CMV Infection	Association of a Neonatal weight below the 10th centile and Neonatal CMV infection	baseline
Secondary	Microcephaly as a Risk Factor for Congenital CMV Infection	Association of a Neonatal head circumference below the 10th centile and Neonatal CMV infection	baseline
Secondary	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
Secondary	Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection	Association of hepatomegaly or splenomegaly and Neonatal CMV infection	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Hearing abnormality as a Risk Factor for Congenital CMV Infection	Failure at hearing screening as a Risk Factor for Congenital CMV Infection	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Biological hepatic abnormality as a consequence of Congenital CMV Infection	Association of any biological hepatic abnormality with a diagnosed Neonatal CMV infection	baseline
Secondary	Hearing abnormality as a consequence of Congenital CMV Infection	Association of failure at hearing screening with a diagnosed Neonatal CMV infection	baseline