Clinical trial NCT05754879: Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Cytomegalovirus Infection
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 479
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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).


Eligibility criteria: 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

Primary outcomes:
measure: Relevance of the Protocol for defining a population at risk
timeFrame: baseline
Secondary outcomes:
measure: Modalities of realisation of screening test
timeFrame: baseline
measure: Maternal CMV infection as a Risk Factor for Congenital CMV Infection
timeFrame: baseline
measure: Hypotrophy as a Risk Factor for Congenital CMV Infection
timeFrame: baseline
measure: Microcephaly as a Risk Factor for Congenital CMV Infection
timeFrame: baseline
measure: Any foetal ultrasound abnormality as a Risk Factor for Congenital CMV Infection
timeFrame: baseline
measure: Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection
timeFrame: baseline
measure: Any neurological abnormality as a Risk Factor for Congenital CMV Infection
timeFrame: baseline
measure: Any blood count cell abnormality as a Risk Factor for Congenital CMV Infection
timeFrame: baseline
measure: Biological hepatic abnormality as a Risk Factor for Congenital CMV Infection
timeFrame: baseline
measure: Hearing abnormality as a Risk Factor for Congenital CMV Infection
timeFrame: baseline
measure: Hypotrophy as a consequence of diagnosed Congenital CMV Infection
timeFrame: baseline
measure: Microcephaly as a consequence of diagnosed Congenital CMV Infection
timeFrame: baseline
measure: Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection
timeFrame: Baseline
measure: Any neurological abnormality as a consequence of Congenital CMV Infection
timeFrame: baseline
measure: Any blood count cell abnormality as a consequence of Congenital CMV Infection
timeFrame: baseline
measure: Biological hepatic abnormality as a consequence of Congenital CMV Infection
timeFrame: baseline
measure: Hearing abnormality as a consequence of Congenital CMV Infection
timeFrame: baseline
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternity Hospital CHRU
Study officials:
References: