Congenital Cytomegalovirus InfectionNCT05754879
Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk
An observational study of Congenital Cytomegalovirus Infection, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 weeks
- Conditions the study is for
- Congenital Cytomegalovirus Infection
- How many people
- 479 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 31 Dec 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 weeks
- All sexes
- No healthy volunteers
- Child
Study population: All NewBorn born between January 2019 and December 2021 who have had Screening Congenital Cytomegalovirus Infection by PCR in saliva
Who may be able to join
- 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
Who cannot join
- No one
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Congenital Cytomegalovirus Infection
- Medical subject headings
- Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevance of the Protocol for defining a population at risk
Comparison between Prevalence in the targeted population and Prevalence in the general Population
Measured: baseline
Secondary outcomes (17)
Modalities of realisation of screening test
Test by PCR in saliva and appropriate indications
Measured: baseline
Maternal CMV infection as a Risk Factor for Congenital CMV Infection
Association between Maternal infection and Neonatal CMV infection
Measured: baseline
Hypotrophy as a Risk Factor for Congenital CMV Infection
Association of a Neonatal weight below the 10th centile and Neonatal CMV infection
Measured: baseline
Microcephaly as a Risk Factor for Congenital CMV Infection
Association of a Neonatal head circumference below the 10th centile and Neonatal CMV infection
Measured: baseline
Any foetal ultrasound abnormality as a Risk Factor for Congenital CMV Infection
Association of any abnormality at fetal ultrasound examination and Neonatal CMV infection
Measured: baseline
Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection
Association of hepatomegaly or splenomegaly and Neonatal CMV infection
Measured: baseline
Any neurological abnormality as a Risk Factor for Congenital CMV Infection
Any neurological abnormality at clinical examination as a Risk Factor for Congenital CMV Infection
Measured: baseline
Any blood count cell abnormality as a Risk Factor for Congenital CMV Infection
Any blood count cell abnormality at biological check up as a Risk Factor for Congenital CMV Infection
Measured: baseline
Biological hepatic abnormality as a Risk Factor for Congenital CMV Infection
Any biological hepatic abnormality at biological check up as a Risk Factor for Congenital
Measured: baseline
Hearing abnormality as a Risk Factor for Congenital CMV Infection
Failure at hearing screening as a Risk Factor for Congenital CMV Infection
Measured: baseline
Hypotrophy as a consequence of diagnosed Congenital CMV Infection
Association of a birth weight below the 10th centile with a diagnosed Neonatal CMV infection
Measured: baseline
Microcephaly as a consequence of diagnosed Congenital CMV Infection
Association of a Neonatal head circumference below the 10th centile with a diagnosed Neonatal CMV infection
Measured: baseline
Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection
Association of an hepatomegaly or spenomegly with a diagnosed Neonatal CMV infection
Measured: Baseline
Any neurological abnormality as a consequence of Congenital CMV Infection
Association of a neurological abnormality at clinical examniation with a diagnosed Neonatal CMV infection
Measured: baseline
Any blood count cell abnormality as a consequence of Congenital CMV Infection
Association of any blood count cell abnormality with a diagnosed Neonatal CMV infection
Measured: baseline
Biological hepatic abnormality as a consequence of Congenital CMV Infection
Association of any biological hepatic abnormality with a diagnosed Neonatal CMV infection
Measured: baseline
Hearing abnormality as a consequence of Congenital CMV Infection
Association of failure at hearing screening with a diagnosed Neonatal CMV infection
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Feb 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 479 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754879
- Sponsor's protocol ID
- 2022PI027
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05754879
- Acronym / sponsor ID
- 2022PI027
- Conditions
- Congenital Cytomegalovirus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- Up to 3 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All NewBorn born between January 2019 and December 2021 who have had Screening Congenital Cytomegalovirus Infection by PCR in saliva
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- No one
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
17 secondary outcomes
Modalities of realisation of screening test
Time frame: baseline
Maternal CMV infection as a Risk Factor for Congenital CMV Infection
Time frame: baseline
Hypotrophy as a Risk Factor for Congenital CMV Infection
Time frame: baseline
Microcephaly as a Risk Factor for Congenital CMV Infection
Time frame: baseline
Any foetal ultrasound abnormality as a Risk Factor for Congenital CMV Infection
Time frame: baseline
Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection
Time frame: baseline
Any neurological abnormality as a Risk Factor for Congenital CMV Infection
Time frame: baseline
Any blood count cell abnormality as a Risk Factor for Congenital CMV Infection
Time frame: baseline
Biological hepatic abnormality as a Risk Factor for Congenital CMV Infection
Time frame: baseline
Hearing abnormality as a Risk Factor for Congenital CMV Infection
Time frame: baseline
Hypotrophy as a consequence of diagnosed Congenital CMV Infection
Time frame: baseline
Microcephaly as a consequence of diagnosed Congenital CMV Infection
Time frame: baseline
Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection
Time frame: Baseline
Any neurological abnormality as a consequence of Congenital CMV Infection
Time frame: baseline
Any blood count cell abnormality as a consequence of Congenital CMV Infection
Time frame: baseline
Biological hepatic abnormality as a consequence of Congenital CMV Infection
Time frame: baseline
Hearing abnormality as a consequence of Congenital CMV Infection
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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Cytomegalovirus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cytomegalovirus Infection, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relevance of the Protocol for defining a population at risk (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.