Clinical trial NCT04822142: Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)
Official title: Congenital Cytomegalovirus Infection in Vietnam: Prevalence, Morbidity and Risk Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prenatal Infection
Congenital Infection
Neonatal Disease
Keywords: CYMEVIE
Cytomegalovirus
Congenital Cytomegalovirus infection
CMV PCR
CMV
cCMV
Lead sponsor: Hanoi Obstetrics and Gynecology Hospital
Sponsor class: OTHER
Collaborators: name: Hôpital Necker-Enfants Malades
First posted: 2021-03-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5,000 mother/neonate pairs

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* Vietnamese pregnant women in the first trimester of pregnancy and at delivery and subsequent live neonates at birth.
* Informed consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of congenital CMV infection in Vietnamese neonates
timeFrame: Within 7 days from birth
Secondary outcomes:
measure: To estimate the prevalence of symptomatic cCMV in neonates
timeFrame: Up to 25 months from recruitment
measure: To estimate the prevalence of cCMV related hearing loss in neonates
timeFrame: Up to 25 months from recruitment
measure: To estimate the prevalence of cCMV related neurological sequelae in neonates
timeFrame: Up to 25 months from recruitment
measure: To estimate CMV seroprevalence in pregnant Vietnamese women
timeFrame: Up to 25 months from recruitment
measure: To evaluate the value of a positive CMV PCR in maternal whole blood in the first trimester to predict infection in the neonates
timeFrame: Up to 25 months from recruitment
measure: To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict infection in the neonates
timeFrame: Up to 25 months from recruitment
measure: To evaluate the value of a positive CMV PCR in maternal saliva in the first trimester to predict cCMV infection in the neonates
timeFrame: Up to 25 months from recruitment
measure: To evaluate the value of a positive CMV PCR in maternal whole blood at delivery to predict infection in the neonates
timeFrame: Up to 25 months from recruitment
measure: To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict infection in the neonates
timeFrame: Up to 25 months from recruitment
measure: 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
timeFrame: Up to 25 months from recruitment
measure: To evaluate the value of a positive CMV PCR in maternal urine in the first trimester to predict a cCMV symptomatic infection in neonates
timeFrame: Up to 25 months from recruitment
measure: 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
timeFrame: Up to 25 months from recruitment
measure: 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
timeFrame: Up to 25 months from recruitment
measure: To evaluate the value of a positive CMV PCR in maternal urine at delivery to predict a cCMV symptomatic infection in neonates
timeFrame: Up to 25 months from recruitment
measure: To evaluate the association between CMV PCR viral load in maternal whole blood at first trimester and at delivery in mothers with infected neonates
timeFrame: Up to 25 months from recruitment
measure: To evaluate the association between CMV PCR viral load in maternal urine at first trimester and at delivery in mothers with infected neonates
timeFrame: Up to 25 months from recruitment
measure: 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
timeFrame: Up to 25 months from recruitment
measure: 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
timeFrame: Up to 25 months from recruitment
measure: To calculate the false positive rate of CMV PCR on neonatal saliva versus on dry blood spot in screening congenital CMV infection
timeFrame: Up to 25 months from recruitment
measure: To calculate the false positive rate of CMV PCR on neonatal saliva versus on urine in screening congenital CMV infection
timeFrame: Up to 25 months from recruitment
measure: To evaluate risks factors for cCMV in Vietnamese women
timeFrame: Up to 25 months from recruitment
measure: To estimate the prevalence of symptomatic cCMV at 2 years of age
timeFrame: Up to 48 months from recruitment
measure: To estimate the prevalence of cCMV related hearing loss at 2 years of age
timeFrame: Up to 48 months from recruitment
measure: To estimate the prevalence of cCMV related neurological sequelae at 2 years of age
timeFrame: Up to 48 months from recruitment
measure: 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
timeFrame: Up to 48 months from recruitment
measure: 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
timeFrame: Up to 48 months from recruitment
measure: 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
timeFrame: Up to 48 months from recruitment
measure: 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
timeFrame: Up to 48 months from recruitment
measure: 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
timeFrame: Up to 48 months from recruitment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Obstetrics and Gynecology Hospital
Study officials:
affiliation: Hôpital Necker-Enfants Malades
name: Yves Ville, MD.PhD
role: STUDY_CHAIR
affiliation: Hôpital Necker-Enfants Malades
name: Marianne Leruez-Ville, MD.PhD
role: STUDY_DIRECTOR
affiliation: Hanoi Obstetrics and Gynecology Hospital
name: Anh Nguyen Duy, MD.PhD
role: STUDY_DIRECTOR
affiliation: Hanoi Obstetrics and Gynecology Hospital
name: Ha Nguyen Thi Thu, MD.PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanoi Obstetrics and Gynecology Hospital
name: Linh Dinh Thuy, MD.PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Leruez-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.
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citation: Ross 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.
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