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| Name | Class |
|---|---|
| Hôpital Necker-Enfants Malades | OTHER |
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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
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of congenital CMV infection in Vietnamese neonates | Number of CMV positive neonates among all tested neonates | Within 7 days from birth |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 25 months from recruitment |
| To estimate the prevalence of cCMV related hearing loss in neonates |
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Inclusion Criteria:
Exclusion Criteria:
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5,000 mother/neonate pairs
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ha Nguyen Thi Thu, MD.PhD | Contact | 0084989661093 | thuha.ivf@gmail.com | |
| Linh Dinh Thuy, MD.PhD | Contact | drdinhlinhobgyn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yves Ville, MD.PhD | Hôpital Necker-Enfants Malades | Study Chair |
| Marianne Leruez-Ville, MD.PhD | Hôpital Necker-Enfants Malades | Study Director |
| Anh Nguyen Duy, MD.PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanoi Obstetrics and Gynecology Hospital | Recruiting | Hanoi | 100000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17579921 | Background | 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. | |
| 28419213 | Background | 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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| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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Maternal whole blood, saliva and urine collected in the first trimester of pregnancy. Maternal whole blood and urine collected at time of delivery. Neonatal saliva sample collected within 72 hours after birth. Heel-prick blood sample on paper within 72 hours after birth. For neonates with positive CMV PCR on saliva sample, neonatal urine during first month will be collected, whole blood at moment of 1st month follow-up will be collected.
Proportion of cCMV related hearing loss in neonates in all cCMV neonates |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Up to 48 months from recruitment |
| Hanoi Obstetrics and Gynecology Hospital |
| Study Director |
| Ha Nguyen Thi Thu, MD.PhD | Hanoi Obstetrics and Gynecology Hospital | Principal Investigator |
| Linh Dinh Thuy, MD.PhD | Hanoi Obstetrics and Gynecology Hospital | Principal Investigator |
| 28116961 | Background | Puhakka 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. |
| 29868783 | Background | Mussi-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. |
| 16615962 | Background | 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. |
| 31102409 | Background | Yamamoto 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. |
| 28151899 | Background | Wang 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. |
| 30596974 | Background | Faure-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. |
| D007239 | Infections |