Prenatal InfectionCYMEVIENCT04822142
Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)
An observational study of Prenatal Infection and Congenital Infection, run by Hanoi Obstetrics and Gynecology Hospital at 1 site in Vietnam.
Trial summary
To estimate the prevalence of congenital CMV infection in Vietnamese neonates and relating morbidity within 2-year follow-up. Along with evaluating the predictive value of the presence and the level of CMV replication in the first trimester in a highly seropositive population Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prenatal Infection, Congenital Infection, Neonatal Disease
- How many people
- 5,000 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Apr 2022to 1 Jun 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 5,000 mother/neonate pairs
Who may be able to join
- Vietnamese pregnant women in the first trimester of pregnancy and at delivery and subsequent live neonates at birth.
- Informed consent
Who cannot join
- Women under 18 years old.
- Miscarriages
- Stillbirths
- Premature delivery before 34th gestational week
- Loss to follow-up maternal monitoring.
- Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality.
Trial locations and contacts
1 site in 1 country.
Linh Dinh Thuy, MD.PhD contact
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Obstetrics and Gynecology Hospital
Hanoi, 100000
HA Nguyen Thi Thu, PhD.MD, 0084989661093, thuha.ivf@gmail.com
LINH Dinh Thuy, PhD.MD, 0084936655779, drdinhlinhhobgyn@gmail.com
About this study
Official title: Congenital Cytomegalovirus Infection in Vietnam: Prevalence, Morbidity and Risk Factors
To estimate the prevalence of congenital CMV infection in Vietnamese neonates and relating morbidity within 2-year follow-up. Along with evaluating the predictive value of the presence and the level of CMV replication in the first trimester in a highly seropositive population
Read the detailed description
Congenital cytomegalovirus infection (cCMV) is the main non-genetic cause of sensorineural hearing loss (SNHL), and a major cause of neuro-disability. High maternal CMV prevalence seems to be consistently associated with high prevalence of cCMV infection but the associated morbidity might be different from one population to another.
There exists no serologic marker useful to differentiate non-primary infection from primary infection. Since the morbidity of cCMV is similar between both primary and non-primary maternal infection, and to be infected in the first trimester is the major risk factor for long-term sequelae in neonates. Hence, it is needed to focus on finding markers that predict cCMV after maternal infection in the first trimester of pregnancy.
To date, the epidemiology of cCMV, the morbidity related to cCMV in Vietnamese population and the predictive value of Cytomegalovirus Polymerase Chain Reaction (CMV PCR) in maternal blood and urine in the first trimester remain unknown. Therefore, it is necessary to conduct this study.
- Conditions
- Prenatal Infection, Congenital Infection, Neonatal Disease
- Keywords
- CYMEVIE, Cytomegalovirus, Congenital Cytomegalovirus infection, CMV PCR, CMV, cCMV
- Medical subject headings
- Infant, Newborn, Diseases, Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of congenital CMV infection in Vietnamese neonates
Number of CMV positive neonates among all tested neonates
Measured: Within 7 days from birth
Secondary outcomes (29)
To estimate the prevalence of symptomatic cCMV in neonates
Proportion of neonates presenting with at least one symptom related to cCMV in all cCMV neonates
Measured: Up to 25 months from recruitment
To estimate the prevalence of cCMV related hearing loss in neonates
Proportion of cCMV related hearing loss in neonates in all cCMV neonates
Measured: Up to 25 months from recruitment
To estimate the prevalence of cCMV related neurological sequelae in neonates
Proportion of cCMV related neurological sequelae in neonates in all cCMV neonates
Measured: Up to 25 months from recruitment
To estimate CMV seroprevalence in pregnant Vietnamese women
Proportion of seropositive women in all tested pregnant women, including mother of CMV positive neonates and control group
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood in the first trimester to predict infection in the neonates
Comparison of the proportion of a positive CMV PCR in maternal whole blood in the first trimester between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict infection in the neonates
Comparison of the proportion of a positive CMV PCR in maternal urine in the first trimester between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict cCMV infection in the neonates
Comparison of the proportion of a positive CMV PCR in maternal saliva in the first trimester between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict infection in the neonates
Comparison of the proportion of a positive CMV PCR in maternal whole blood at delivery between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict infection in the neonates
Comparison of the proportion of a positive CMV PCR in maternal urine at delivery between women who gave birth to an infected neonate and women gave birth to an uninfected neonate from control group
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in whole blood in the first trimester to predict the presence of symptomatic cCMV infection in neonates
Comparison of the proportion of a positive CMV PCR in maternal whole blood in the first trimester between symptomatic infected neonates and asymptomatic infected neonates
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict a cCMV symptomatic infection in neonates
Comparison of the proportion of a positive CMV PCR in maternal urine in the first trimester between symptomatic infected neonates and asymptomatic infected neonates
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict the presence of symptomatic cCMV infection in neonates
Comparison of the proportion of a positive CMV PCR in maternal saliva in the first trimester between symptomatic infected neonates and asymptomatic infected neonates
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict the presence of symptomatic cCMV infection in neonates
Comparison of the proportion of a positive CMV PCR in maternal whole blood at delivery between symptomatic infected neonates and asymptomatic infected neonates
Measured: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict a cCMV symptomatic infection in neonates
Comparison of the proportion of a positive CMV PCR in maternal urine at delivery between symptomatic infected neonates and asymptomatic infected neonates
Measured: Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with infected neonates
Evaluation the change of CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with infected neonates
Measured: Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with infected neonates
Evaluation the change of CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with infected neonates
Measured: Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with uninfected neonates in control group
Evaluation the change of CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with uninfected neonates in control group
Measured: Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with uninfected neonates in control group
Evaluation the change of CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with uninfected neonates in control group
Measured: Up to 25 months from recruitment
To calculate the false positive rate of CMV PCR on neonatal saliva versus on dry blood spot in screening congenital CMV infection
Calculation of the rate of positive CMV PCR on neonatal saliva with a negative result on CMV PCR on neonatal dry blood spot in all CMV positive on neonatal saliva
Measured: Up to 25 months from recruitment
To calculate the false positive rate of CMV PCR on neonatal saliva versus on urine in screening congenital CMV infection
Calculation of the rate of positive CMV PCR on neonatal saliva with a negative result on CMV PCR on neonatal urine in all CMV positive on neonatal saliva
Measured: Up to 25 months from recruitment
To evaluate risks factors for cCMV in Vietnamese women
Factors that may differ between mothers of uninfected neonates and mothers of infected ones regarding maternal age, parity, gestity, twin pregnancy, known health conditions including hypertension, diabetes, HIV, auto immune diseases and living conditions will be analyzed
Measured: Up to 25 months from recruitment
To estimate the prevalence of symptomatic cCMV at 2 years of age
Proportion of infants presenting with at least one symptom related to cCMV at 2 years of age in all cCMV infants
Measured: Up to 48 months from recruitment
To estimate the prevalence of cCMV related hearing loss at 2 years of age
Proportion of infants with cCMV related hearing loss at 2 years of age in all cCMV infants
Measured: Up to 48 months from recruitment
To estimate the prevalence of cCMV related neurological sequelae at 2 years of age
Proportion of infants with cCMV related neurological sequelae at 2 years of age in all cCMV infants
Measured: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood in the first trimester to predict the cCMV long-term sequelae at the age of 2 years
Comparison of the proportion of a positive CMV PCR in maternal whole blood in the first trimester between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Measured: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict the cCMV long-term sequelae at the age of 2 years
Comparison of the proportion of a positive CMV PCR in maternal urine in the first trimester between between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Measured: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict the cCMV long-term sequelae at the age of 2 years
Comparison of the proportion of a positive CMV PCR in maternal saliva in the first trimester between between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Measured: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict the cCMV long-term sequelae at the age of 2 years
Comparison of the proportion of a positive CMV PCR in maternal whole blood at delivery between between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Measured: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict the cCMV long-term sequelae at the age of 2 years
Comparison of the proportion of a positive CMV PCR in maternal urine at delivery between between infected infants with long-term sequelae at 2 years of age and infected infants without long-term sequelae at 2 years of age
Measured: Up to 48 months from recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Apr 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Prenatal InfectionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hanoi Obstetrics and Gynecology Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Responsible party
- Sponsor
- Investigators
- Yves Ville, MD.PhD, Study chair, Hôpital Necker-Enfants MaladesMarianne Leruez-Ville, MD.PhD, Study director, Hôpital Necker-Enfants MaladesAnh Nguyen Duy, MD.PhD, Study director, Hanoi Obstetrics and Gynecology HospitalHa Nguyen Thi Thu, MD.PhD, Principal investigator, Hanoi Obstetrics and Gynecology HospitalLinh Dinh Thuy, MD.PhD, Principal investigator, Hanoi Obstetrics and Gynecology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822142
- Sponsor's protocol ID
- PSHN.0003.2021
- Acronym
- CYMEVIE
- Status last verified
- Feb 2024
- First submitted
- 25 Mar 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined
Publications
Kenneson A, Cannon MJ. Review and meta-analysis of the epidemiology of congenital cytomegalovirus (CMV) infection. Rev Med Virol. 2007 Jul-Aug;17(4):253-76. doi: 10.1002/rmv.535.
PubMed 17579921Leruez-Ville M, Magny JF, Couderc S, Pichon C, Parodi M, Bussieres L, Guilleminot T, Ghout I, Ville Y. Risk Factors for Congenital Cytomegalovirus Infection Following Primary and Nonprimary Maternal Infection: A Prospective Neonatal Screening Study Using Polymerase Chain Reaction in Saliva. Clin Infect Dis. 2017 Aug 1;65(3):398-404. doi: 10.1093/cid/cix337.
PubMed 28419213Puhakka L, Renko M, Helminen M, Peltola V, Heiskanen-Kosma T, Lappalainen M, Surcel HM, Lonnqvist T, Saxen H. Primary versus non-primary maternal cytomegalovirus infection as a cause of symptomatic congenital infection - register-based study from Finland. Infect Dis (Lond). 2017 Jun;49(6):445-453. doi: 10.1080/23744235.2017.1279344. Epub 2017 Jan 24.
PubMed 28116961Mussi-Pinhata MM, Yamamoto AY, Aragon DC, Duarte G, Fowler KB, Boppana S, Britt WJ. Seroconversion for Cytomegalovirus Infection During Pregnancy and Fetal Infection in a Highly Seropositive Population: "The BraCHS Study". J Infect Dis. 2018 Sep 8;218(8):1200-1204. doi: 10.1093/infdis/jiy321.
PubMed 29868783Ross SA, Fowler KB, Ashrith G, Stagno S, Britt WJ, Pass RF, Boppana SB. Hearing loss in children with congenital cytomegalovirus infection born to mothers with preexisting immunity. J Pediatr. 2006 Mar;148(3):332-6. doi: 10.1016/j.jpeds.2005.09.003.
PubMed 16615962Yamamoto AY, Anastasio ART, Massuda ET, Isaac ML, Manfredi AKS, Cavalcante JMS, Carnevale-Silva A, Fowler KB, Boppana SB, Britt WJ, Mussi-Pinhata MM. Contribution of Congenital Cytomegalovirus Infection to Permanent Hearing Loss in a Highly Seropositive Population: The Brazilian Cytomegalovirus Hearing and Maternal Secondary Infection Study. Clin Infect Dis. 2020 Mar 17;70(7):1379-1384. doi: 10.1093/cid/ciz413.
PubMed 31102409Wang S, Wang T, Zhang W, Liu X, Wang X, Wang H, He X, Zhang S, Xu S, Yu Y, Jia X, Wang M, Xu A, Ma W, Amin MM, Bialek SR, Dollard SC, Wang C. Cohort study on maternal cytomegalovirus seroprevalence and prevalence and clinical manifestations of congenital infection in China. Medicine (Baltimore). 2017 Feb;96(5):e6007. doi: 10.1097/MD.0000000000006007.
PubMed 28151899Faure-Bardon V, Magny JF, Parodi M, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Astruc D, Patural H, Pladys P, Parat S, Guillois B, Garenne A, Bussieres L, Guilleminot T, Stirnemann J, Ghout I, Ville Y, Leruez-Ville M. Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy. Clin Infect Dis. 2019 Oct 15;69(9):1526-1532. doi: 10.1093/cid/ciy1128.
PubMed 30596974
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Cytomegalovirus Infection in Vietnam: Prevalence, Morbidity and Risk Factors
- ClinicalTrials.gov ID
- NCT04822142
- Acronym / sponsor ID
- CYMEVIE / PSHN.0003.2021
- Conditions
- Prenatal Infection, Congenital Infection, Neonatal Disease
- Keywords
- CYMEVIE, Cytomegalovirus, Congenital Cytomegalovirus infection, CMV PCR, CMV, cCMV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hanoi Obstetrics and Gynecology HospitalUniversity, hospital or other
- Collaborators
- Hôpital Necker-Enfants Malades
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 Mar 2021 (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.
To estimate the prevalence of congenital CMV infection in Vietnamese neonates and relating morbidity within 2-year follow-up. Along with evaluating the predictive value of the presence and the level of CMV replication in the first trimester in a highly seropositive population
Detailed description
Congenital cytomegalovirus infection (cCMV) is the main non-genetic cause of sensorineural hearing loss (SNHL), and a major cause of neuro-disability. High maternal CMV prevalence seems to be consistently associated with high prevalence of cCMV infection but the associated morbidity might be different from one population to another.
There exists no serologic marker useful to differentiate non-primary infection from primary infection. Since the morbidity of cCMV is similar between both primary and non-primary maternal infection, and to be infected in the first trimester is the major risk factor for long-term sequelae in neonates. Hence, it is needed to focus on finding markers that predict cCMV after maternal infection in the first trimester of pregnancy.
To date, the epidemiology of cCMV, the morbidity related to cCMV in Vietnamese population and the predictive value of Cytomegalovirus Polymerase Chain Reaction (CMV PCR) in maternal blood and urine in the first trimester remain unknown. Therefore, it is necessary to conduct this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 5,000 mother/neonate pairs
Key inclusion criteria (2 listed)
- Vietnamese pregnant women in the first trimester of pregnancy and at delivery and subsequent live neonates at birth.
- Informed consent
Key exclusion criteria (6 listed)
- Women under 18 years old.
- Miscarriages
- Stillbirths
- Premature delivery before 34th gestational week
- Loss to follow-up maternal monitoring.
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
Proportion of congenital CMV infection in Vietnamese neonates
Time frame: Within 7 days from birth
Number of CMV positive neonates among all tested neonates
29 secondary outcomes
To estimate the prevalence of symptomatic cCMV in neonates
Time frame: Up to 25 months from recruitment
To estimate the prevalence of cCMV related hearing loss in neonates
Time frame: Up to 25 months from recruitment
To estimate the prevalence of cCMV related neurological sequelae in neonates
Time frame: Up to 25 months from recruitment
To estimate CMV seroprevalence in pregnant Vietnamese women
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood in the first trimester to predict infection in the neonates
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict infection in the neonates
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict cCMV infection in the neonates
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict infection in the neonates
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict infection in the neonates
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in whole blood in the first trimester to predict the presence of symptomatic cCMV infection in neonates
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict a cCMV symptomatic infection in neonates
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict the presence of symptomatic cCMV infection in neonates
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict the presence of symptomatic cCMV infection in neonates
Time frame: Up to 25 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict a cCMV symptomatic infection in neonates
Time frame: Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with infected neonates
Time frame: Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with infected neonates
Time frame: Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with uninfected neonates in control group
Time frame: Up to 25 months from recruitment
To evaluate the association between CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with uninfected neonates in control group
Time frame: Up to 25 months from recruitment
To calculate the false positive rate of CMV PCR on neonatal saliva versus on dry blood spot in screening congenital CMV infection
Time frame: Up to 25 months from recruitment
To calculate the false positive rate of CMV PCR on neonatal saliva versus on urine in screening congenital CMV infection
Time frame: Up to 25 months from recruitment
To evaluate risks factors for cCMV in Vietnamese women
Time frame: Up to 25 months from recruitment
To estimate the prevalence of symptomatic cCMV at 2 years of age
Time frame: Up to 48 months from recruitment
To estimate the prevalence of cCMV related hearing loss at 2 years of age
Time frame: Up to 48 months from recruitment
To estimate the prevalence of cCMV related neurological sequelae at 2 years of age
Time frame: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood in the first trimester to predict the cCMV long-term sequelae at the age of 2 years
Time frame: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict the cCMV long-term sequelae at the age of 2 years
Time frame: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict the cCMV long-term sequelae at the age of 2 years
Time frame: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict the cCMV long-term sequelae at the age of 2 years
Time frame: Up to 48 months from recruitment
To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict the cCMV long-term sequelae at the age of 2 years
Time frame: Up to 48 months from recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 17579921Kenneson A, Cannon MJ. Review and meta-analysis of the epidemiology of congenital cytomegalovirus (CMV) infection. Rev Med Virol. 2007 Jul-Aug;17(4):253-76. doi: 10.1002/rmv.535.
- Background: PubMed 28419213Leruez-Ville M, Magny JF, Couderc S, Pichon C, Parodi M, Bussieres L, Guilleminot T, Ghout I, Ville Y. Risk Factors for Congenital Cytomegalovirus Infection Following Primary and Nonprimary Maternal Infection: A Prospective Neonatal Screening Study Using Polymerase Chain Reaction in Saliva. Clin Infect Dis. 2017 Aug 1;65(3):398-404. doi: 10.1093/cid/cix337.
- Background: PubMed 28116961Puhakka L, Renko M, Helminen M, Peltola V, Heiskanen-Kosma T, Lappalainen M, Surcel HM, Lonnqvist T, Saxen H. Primary versus non-primary maternal cytomegalovirus infection as a cause of symptomatic congenital infection - register-based study from Finland. Infect Dis (Lond). 2017 Jun;49(6):445-453. doi: 10.1080/23744235.2017.1279344. Epub 2017 Jan 24.
- Background: PubMed 29868783Mussi-Pinhata MM, Yamamoto AY, Aragon DC, Duarte G, Fowler KB, Boppana S, Britt WJ. Seroconversion for Cytomegalovirus Infection During Pregnancy and Fetal Infection in a Highly Seropositive Population: "The BraCHS Study". J Infect Dis. 2018 Sep 8;218(8):1200-1204. doi: 10.1093/infdis/jiy321.
- Background: PubMed 16615962Ross SA, Fowler KB, Ashrith G, Stagno S, Britt WJ, Pass RF, Boppana SB. Hearing loss in children with congenital cytomegalovirus infection born to mothers with preexisting immunity. J Pediatr. 2006 Mar;148(3):332-6. doi: 10.1016/j.jpeds.2005.09.003.
- Background: PubMed 31102409Yamamoto AY, Anastasio ART, Massuda ET, Isaac ML, Manfredi AKS, Cavalcante JMS, Carnevale-Silva A, Fowler KB, Boppana SB, Britt WJ, Mussi-Pinhata MM. Contribution of Congenital Cytomegalovirus Infection to Permanent Hearing Loss in a Highly Seropositive Population: The Brazilian Cytomegalovirus Hearing and Maternal Secondary Infection Study. Clin Infect Dis. 2020 Mar 17;70(7):1379-1384. doi: 10.1093/cid/ciz413.
- Background: PubMed 28151899Wang S, Wang T, Zhang W, Liu X, Wang X, Wang H, He X, Zhang S, Xu S, Yu Y, Jia X, Wang M, Xu A, Ma W, Amin MM, Bialek SR, Dollard SC, Wang C. Cohort study on maternal cytomegalovirus seroprevalence and prevalence and clinical manifestations of congenital infection in China. Medicine (Baltimore). 2017 Feb;96(5):e6007. doi: 10.1097/MD.0000000000006007.
- Background: PubMed 30596974Faure-Bardon V, Magny JF, Parodi M, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Astruc D, Patural H, Pladys P, Parat S, Guillois B, Garenne A, Bussieres L, Guilleminot T, Stirnemann J, Ghout I, Ville Y, Leruez-Ville M. Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy. Clin Infect Dis. 2019 Oct 15;69(9):1526-1532. doi: 10.1093/cid/ciy1128.
- Individual participant dataSharing planned: No. To be determined
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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.
Linh Dinh Thuy, MD.PhD contact
Yves Ville, MD.PhD study chair
Hôpital Necker-Enfants Malades
Marianne Leruez-Ville, MD.PhD study director
Hôpital Necker-Enfants Malades
Anh Nguyen Duy, MD.PhD study director
Hanoi Obstetrics and Gynecology Hospital
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 Prenatal Infection and Congenital Infection, run by Hanoi Obstetrics and Gynecology Hospital at 1 site in Vietnam.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Mar 2024. 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 Vietnam. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ha Nguyen Thi Thu, MD.PhD (0084989661093, thuha.ivf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of congenital CMV infection in Vietnamese neonates (time frame: Within 7 days from birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04822142, which also lists 8 linked publications.
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 1 Mar 2024.