NCT05754879

Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk

Completed Last updated 6 March 2023

What this trial tests

trial in Congenital Cytomegalovirus Infection in 479 participants. Completed in 31 December 2022.

Timeline

1 February 2019

Primary endpoint
31 December 2021

31 December 2022

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Status	Completed
Study type	OBSERVATIONAL
Enrollment	479
Start date	1 February 2019
Primary completion	31 December 2021
Estimated completion	31 December 2022
Sites	1 location across France

Conditions studied

• Congenital Cytomegalovirus Infection — all drugs for Congenital Cytomegalovirus Infection →

Sponsor

Central Hospital, Nancy, France

Who can join

Under 3 Weeks, any sex, with Congenital Cytomegalovirus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.