Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk
Study Details
Study Description
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).
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Study Design
Outcome Measures
Primary Outcome Measures
- Relevance of the Protocol for defining a population at risk [baseline]
Comparison between Prevalence in the targeted population and Prevalence in the general Population
Secondary Outcome Measures
- Modalities of realisation of screening test [baseline]
Test by PCR in saliva and appropriate indications
- Maternal CMV infection as a Risk Factor for Congenital CMV Infection [baseline]
Association between Maternal infection and Neonatal CMV infection
- Hypotrophy as a Risk Factor for Congenital CMV Infection [baseline]
Association of a Neonatal weight below the 10th centile and Neonatal CMV infection
- Microcephaly as a Risk Factor for Congenital CMV Infection [baseline]
Association of a Neonatal head circumference below the 10th centile and Neonatal CMV infection
- Any foetal ultrasound abnormality as a Risk Factor for Congenital CMV Infection [baseline]
Association of any abnormality at fetal ultrasound examination and Neonatal CMV infection
- Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection [baseline]
Association of hepatomegaly or splenomegaly and Neonatal CMV infection
- Any neurological abnormality as a Risk Factor for Congenital CMV Infection [baseline]
Any neurological abnormality at clinical examination as a Risk Factor for Congenital CMV Infection
- Any blood count cell abnormality as a Risk Factor for Congenital CMV Infection [baseline]
Any blood count cell abnormality at biological check up as a Risk Factor for Congenital CMV Infection
- Biological hepatic abnormality as a Risk Factor for Congenital CMV Infection [baseline]
Any biological hepatic abnormality at biological check up as a Risk Factor for Congenital
- Hearing abnormality as a Risk Factor for Congenital CMV Infection [baseline]
Failure at hearing screening as a Risk Factor for Congenital CMV Infection
- Hypotrophy as a consequence of diagnosed Congenital CMV Infection [baseline]
Association of a birth weight below the 10th centile with a diagnosed Neonatal CMV infection
- Microcephaly as a consequence of diagnosed Congenital CMV Infection [baseline]
Association of a Neonatal head circumference below the 10th centile with a diagnosed Neonatal CMV infection
- Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection [Baseline]
Association of an hepatomegaly or spenomegly with a diagnosed Neonatal CMV infection
- Any neurological abnormality as a consequence of Congenital CMV Infection [baseline]
Association of a neurological abnormality at clinical examniation with a diagnosed Neonatal CMV infection
- Any blood count cell abnormality as a consequence of Congenital CMV Infection [baseline]
Association of any blood count cell abnormality with a diagnosed Neonatal CMV infection
- Biological hepatic abnormality as a consequence of Congenital CMV Infection [baseline]
Association of any biological hepatic abnormality with a diagnosed Neonatal CMV infection
- Hearing abnormality as a consequence of Congenital CMV Infection [baseline]
Association of failure at hearing screening with a diagnosed Neonatal CMV infection
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newborn born between Bebruary 2019 and December 2021 in the Regional Maternity Hospital of Nancy
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Patients who were screened for congenital CMV infection by salivary PCR
Exclusion Criteria:
- No one
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maternity Hospital CHRU | Nancy | France | 54000 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022PI027