Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)

NCT04822142 | Recruiting DMC

• 1 other identifier: PSHN.0003.2021
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Conditions

Prenatal Infection; Congenital Infection; Neonatal Disease

Keywords

CYMEVIE; Cytomegalovirus; Congenital Cytomegalovirus infection; CMV PCR; CMV; cCMV

Outcome Measures

Primary Outcomes (1)

• Proportion of congenital CMV infection in Vietnamese neonates

  Number of CMV positive neonates among all tested neonates

  Within 7 days from birth

Secondary Outcomes (29)

• To estimate the prevalence of symptomatic cCMV in neonates

  Up to 25 months from recruitment

• To estimate the prevalence of cCMV related hearing loss in neonates

  Up to 25 months from recruitment

• To estimate the prevalence of cCMV related neurological sequelae in neonates

  Up to 25 months from recruitment

• To estimate CMV seroprevalence in pregnant Vietnamese women

  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

  Up to 25 months from recruitment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

5,000 mother/neonate pairs

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Obstetrics and Gynecology Hospital: lead
• Hôpital Necker-Enfants Malades: collaborator

Study Sites (1)

Hanoi Obstetrics and Gynecology Hospital

Hanoi, 100000, Vietnam

RECRUITING

Related Publications (8)

• 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.

  PMID: 17579921 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.

  PMID: 28419213 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.

  PMID: 28116961 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.

  PMID: 29868783 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.

  PMID: 16615962 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.

  PMID: 31102409 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.

  PMID: 28151899 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.

  PMID: 30596974 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Infant, Newborn, Diseases; Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• 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

  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

Central Study Contacts

Ha Nguyen Thi Thu, MD.PhD

CONTACT

0084989661093; thuha.ivf@gmail.com

Linh Dinh Thuy, MD.PhD

CONTACT

drdinhlinhobgyn@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 30, 2021
• Study Start: April 1, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)