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NCT Number: NCT05754879

Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk

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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Key information

Conditions

Congenital Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

Up to 3 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Maternity Hospital CHRU

Nancy, 54000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Relevance of the Protocol for defining a population at risk

    Time frame: baseline

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

Secondary outcomes

  1. Modalities of realisation of screening test

    Time frame: baseline

    Test by PCR in saliva and appropriate indications

  2. Maternal CMV infection as a Risk Factor for Congenital CMV Infection

    Time frame: baseline

    Association between Maternal infection and Neonatal CMV infection

  3. Hypotrophy as a Risk Factor for Congenital CMV Infection

    Time frame: baseline

    Association of a Neonatal weight below the 10th centile and Neonatal CMV infection

  4. Microcephaly as a Risk Factor for Congenital CMV Infection

    Time frame: baseline

    Association of a Neonatal head circumference below the 10th centile and Neonatal CMV infection

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

    Time frame: baseline

    Association of any abnormality at fetal ultrasound examination and Neonatal CMV infection

  6. Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection

    Time frame: baseline

    Association of hepatomegaly or splenomegaly and Neonatal CMV infection

  7. Any neurological abnormality as a Risk Factor for Congenital CMV Infection

    Time frame: baseline

    Any neurological abnormality at clinical examination as a Risk Factor for Congenital CMV Infection

  8. Any blood count cell abnormality as a Risk Factor for Congenital CMV Infection

    Time frame: baseline

    Any blood count cell abnormality at biological check up as a Risk Factor for Congenital CMV Infection

  9. Biological hepatic abnormality as a Risk Factor for Congenital CMV Infection

    Time frame: baseline

    Any biological hepatic abnormality at biological check up as a Risk Factor for Congenital

  10. Hearing abnormality as a Risk Factor for Congenital CMV Infection

    Time frame: baseline

    Failure at hearing screening as a Risk Factor for Congenital CMV Infection

  11. Hypotrophy as a consequence of diagnosed Congenital CMV Infection

    Time frame: baseline

    Association of a birth weight below the 10th centile with a diagnosed Neonatal CMV infection

  12. Microcephaly as a consequence of diagnosed Congenital CMV Infection

    Time frame: baseline

    Association of a Neonatal head circumference below the 10th centile with a diagnosed Neonatal CMV infection

  13. Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection

    Time frame: Baseline

    Association of an hepatomegaly or spenomegly with a diagnosed Neonatal CMV infection

  14. Any neurological abnormality as a consequence of Congenital CMV Infection

    Time frame: baseline

    Association of a neurological abnormality at clinical examniation with a diagnosed Neonatal CMV infection

  15. Any blood count cell abnormality as a consequence of Congenital CMV Infection

    Time frame: baseline

    Association of any blood count cell abnormality with a diagnosed Neonatal CMV infection

  16. Biological hepatic abnormality as a consequence of Congenital CMV Infection

    Time frame: baseline

    Association of any biological hepatic abnormality with a diagnosed Neonatal CMV infection

  17. Hearing abnormality as a consequence of Congenital CMV Infection

    Time frame: baseline

    Association of failure at hearing screening with a diagnosed Neonatal CMV infection

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 6, 2023
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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