## Protocol Section
### Identification Module
**NCT ID:** NCT05754879

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2022PI027
#### Organization
**Class:** OTHER
**Full Name:** Central Hospital, Nancy, France
### Status Module
#### Completion Date
**Date:** 2022-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-06

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2019-02-01

**Type:** ACTUAL

**Status Verified Date:** 2023-02

#### Study First Post Date
**Date:** 2023-03-06
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-13
**Study First Submit QC Date:** 2023-02-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Central Hospital, Nancy, France

#### Responsible Party

**Investigator Affiliation:** Central Hospital, Nancy, France

**Investigator Full Name:** Jean-Michel HASCOET

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Congenital Cytomegalovirus Infection

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 479

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Years

### Outcomes Module

#### Primary Outcomes

**Description:** Comparison between Prevalence in the targeted population and Prevalence in the general Population

**Measure:** Relevance of the Protocol for defining a population at risk

**Time Frame:** baseline

#### Secondary Outcomes

**Description:** Test by PCR in saliva and appropriate indications

**Measure:** Modalities of realisation of screening test

**Time Frame:** baseline

**Description:** Association between Maternal infection and Neonatal CMV infection

**Measure:** Maternal CMV infection as a Risk Factor for Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Hypotrophy as a Risk Factor for Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Microcephaly as a Risk Factor for Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Any foetal ultrasound abnormality as a Risk Factor for Congenital CMV Infection

**Time Frame:** baseline

**Description:** Association of hepatomegaly or splenomegaly and Neonatal CMV infection

**Measure:** Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Any neurological abnormality as a Risk Factor for Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Any blood count cell abnormality as a Risk Factor for Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Biological hepatic abnormality as a Risk Factor for Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Hearing abnormality as a Risk Factor for Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Hypotrophy as a consequence of diagnosed Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Microcephaly as a consequence of diagnosed Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection

**Time Frame:** Baseline

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

**Measure:** Any neurological abnormality as a consequence of Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Any blood count cell abnormality as a consequence of Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Biological hepatic abnormality as a consequence of Congenital CMV Infection

**Time Frame:** baseline

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

**Measure:** Hearing abnormality as a consequence of Congenital CMV Infection

**Time Frame:** baseline

### Eligibility Module

**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

**Maximum Age:** 3 Weeks

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** All NewBorn born between January 2019 and December 2021 who have had Screening Congenital Cytomegalovirus Infection by PCR in saliva

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nancy

**Country:** France

**Facility:** Maternity Hospital CHRU

**Zip:** 54000

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000006566

- Term: Herpesviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6791

- Name: Cytomegalovirus Infections

- Relevance: HIGH

- As Found: Cytomegalovirus Infections

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M9643

- Name: Herpesviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: T1720

- Name: Cytomegalic Inclusion Disease

- Relevance: HIGH

- As Found: Cytomegalovirus Infections

- ID: T1480

- Name: Congenital Cytomegalovirus

- Relevance: HIGH

- As Found: Congenital Cytomegalovirus

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000003586

- Term: Cytomegalovirus Infections

### Misc Info Module

- Version Holder: 2024-05-24
