Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero

NCT01923636 | Completed

• 2 other identifiers: P120114AOM12196
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to validate , in the neonatal period, a prognostic score for the development of neurosensorineural sequelae at 1 year and at 2 years in neonates infected in utero by cytomegalovirus. This score will be based on clinical, imaging and biological criteria . The second objective of the study is to estimate the prevalence of this infection in France and to describe its epidemiology through the screening of 12,000 consecutive neonates.

Conditions

Congenital Cytomegalovirus Infection

Keywords

Cytomegalovirus, congenital, handicap

Outcome Measures

Primary Outcomes (1)

• Prognostic value of neonatal markers (clinical, imaging and biological) for the development of neurosensorial sequelae at 1 year of age

  Assessment will include standardised clinical evaluation, cerebral ultrasound, cerebral MRI, audiometric tests, developmental tests, virological tests (viral load in blood and saliva) and immunological tests (cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK) and cytokines).

  One year

Secondary Outcomes (5)

• to evaluate the prevalence of congenital CMV in France:

  At birth

• Prognosis value of antenatal imaging

  one year

• Prognostic value of the periodic measurement of the kinetics of viral load shedding

  One year

• neurodevelopmental and sensorineural sequelae according to the type of maternal infectionsequelae

  One year

• Prevalence and description of congenital CMV infection in 10,000 French neonates

  1 week

Study Arms (1)

detection of CMV

OTHER

Cohort of neonates less than 1 month with congenital CMV infection at birth objectified by the detection of CMV in a urine sample, in saliva or blood (fresh or Guthrie card) obtained in the first 10 days life

Other: detection of CMV

Interventions

detection of CMV OTHER

Clinical, radiological and laboratory (virological and immunological) standardized reports

detection of CMV

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Main objective: Neonate less than 1 month with congenital CMV infection at birth objectified by the detection of CMV in a urine sample, in saliva or blood (fresh or Guthrie card) obtained in the first 10 days life
• Whose parents accept regular monitoring by the paediatrician investigator
• For which a medical examination has been made
• Affiliated with a social security system
• And whose mother has given its written consent to the participation of their child to study

You may not qualify if:

• \- Children participating in an interventional study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Related Publications (4)

• Fourgeaud J, Magny JF, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Minodier P, Astruc D, Patural H, Ugolin M, Parat S, Guillois B, Garenne A, Guilleminot T, Parodi M, Bussieres L, Ville Y, Leruez-Ville M. Clinical Value of Serial Quantitative Analysis of Cytomegalovirus DNA in Blood and Saliva Over the First 24 Months of Life in Congenital Infection: The French Cymepedia Cohort. J Pediatr. 2023 Feb;253:197-204.e5. doi: 10.1016/j.jpeds.2022.09.040. Epub 2022 Sep 28.

  PMID: 36181870 BACKGROUND

• Leruez-Ville M, Ren S, Magny JF, Jacquemard F, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Minodier P, Astruc D, Patural H, Ugolin M, Parat S, Guillois B, Garenne A, Parodi M, Bussieres L, Stirnemann J, Sonigo P, Millischer AE, Ville Y. Accuracy of prenatal ultrasound screening to identify fetuses infected by cytomegalovirus which will develop severe long-term sequelae. Ultrasound Obstet Gynecol. 2021 Jan;57(1):97-104. doi: 10.1002/uog.22056.

  PMID: 32339337 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

• 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

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Laurence Bussieres, MD

  APHP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 15, 2013
• Study Start: September 9, 2013
• Primary Completion: January 30, 2021
• Study Completion: May 16, 2022
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

FR (1)