NCT03973359

Brief Summary

Human cytomegalovirus (HCMV) is the leading infectious agent causing congenital disabilities such as mental retardation, psychomotor delay, hearing loss, speech and language disabilities, behavioural disorders and visual impairment. About 0.6% newborns are HCMV-congenitally infected and, among these, about 20% are symptomatic at birth or will develop long-term sequelae. The public health impact of congenital HCMV is substantial although greatly unrecognized. In Italy, estimated direct costs per affected child exceed €100.000 for a total of €60-70M. HCMV is also a significant cause of infection/disease in the immunocompromised host. Epidemiological studies and population-based models have preliminarily documented that most of the burden associated to congenital HCMV would be due to non-primary maternal infection. Presently, reinfections are believed to be responsible for the great majority of infected fetuses born to immune mothers. This study addresses incidence, outcome and prevention of congenital HCMV infection in seropositive pregnant women.The study includes 2 parts: part 1 in which the incidence and outcome of congenital HCMV is investigated in a large population of HCMV seropositive pregnant women and HCMV shedding and immune response is closely monitored in a subset of participants (nested study); part 2 in which the efficacy of an hygiene intervention is assessed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

2.8 years

First QC Date

May 20, 2019

Last Update Submit

May 31, 2019

Conditions

Congenital Cytomegalovirus InfectionMaternal Cytomegalovirus Infection

Outcome Measures

Primary Outcomes (2)

  • Part 1. Epidemiology study. Incidence and clinical outcome of congenital HCMV infection in pregnant women with preconception immunity.

    Number of infants with ascertained congenital infection.

    Within 21 days of life

  • Part 2. Prevention study. Efficacy of hygiene counseling in reducing congenital HCMV infection in pregnant women with preconception immunity.

    Number of infants with ascertained congenital infection born to HCMV seropositive women informed about hygiene measures compared to the number of newborns with congenital infection diagnosed in Part 1.

    Within 21 days of life

Secondary Outcomes (11)

  • Frequency of non-primary infections during pregnancy (Nested study)

    10, 20, 30, 40 gestation weeks

  • Frequency of HCMV re-infections vs re-activations during pregnancy (Nested study)

    10, 20, 30, 40 gestation weeks

  • Antigen-specific IgG levels in non-primary infection during pregnancy (Nested study)

    10, 20, 30, 40 gestation weeks

  • Antigen-specific IgM levels in non-primary infection during pregnancy (Nested study)

    10, 20, 30, 40 gestation weeks

  • Neutralizing antibody titers in non-primary infection during pregnancy (Nested study)

    10, 20, 30, 40 gestation weeks

  • +6 more secondary outcomes

Study Arms (2)

Epidemiology

NO INTERVENTION

HCMV-seropositive pregnant women receiving standard care

Prevention

EXPERIMENTAL

HCMV-seropositive pregnant women receiving hygienic information

Behavioral: Hygienic recommendations

Interventions

Hygienic recommendationsBEHAVIORAL

Recommendation of protective behaviours such as frequent hand washing and avoiding risky behaviours such as kissing young children on the mouth or cheeks and sharing utensils, foods etc.

Prevention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (≥ 18 years old) pregnant women at ≤13 weeks gestation
  • Presence of HCMV IgG and absence of IgM or presence of high avidity IgG with or without IgM
  • Presence of HCMV-specific IgG and absence of IgM or presence of high avidity IgG in case of positive IgM at ≤13 weeks gestation documented by medical report or by retrospective antibody determination on samples stored at ≤13 weeks (for women enrolled at delivery)
  • Willingness to participate in the study
  • Ability to understand information material
  • Written informed consent

You may not qualify if:

  • Unreliable women as judged by the investigator
  • Women not willing to give written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Poliambulanza Brescia

Brescia, 25124, Italy

RECRUITING

ASST Vimercate (Ospedale di Carate Brianza)

Carate Brianza, 20841, Italy

RECRUITING

ASST Monza (presidio di Desio)

Desio, 20832, Italy

RECRUITING

Fondazione IRCCS Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Ospedale Macedonio Melloni (ASST FBF-Sacco)

Milan, 20129, Italy

RECRUITING

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Ospedale Buzzi (ASST FBF-Sacco)

Milan, 20154, Italy

RECRUITING

Ospedale Sacco (ASST FBF-Sacco)

Milan, 20157, Italy

RECRUITING

Fondazione Monza Brianza per il Bambino e la sua Mamma

Monza, 20900, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

RECRUITING

ASST dei Sette Laghi (Ospedale Filippo Del Ponte)

Varese, 21100, Italy

ACTIVE NOT RECRUITING

Related Publications (1)

  • Lilleri D, Tassis B, Pugni L, Ronchi A, Pietrasanta C, Spinillo A, Arossa A, Achille C, Vergani P, Ornaghi S, Riboni S, Cavoretto P, Candiani M, Gaeta G, Prefumo F, Fratelli N, Fichera A, Vignali M, Barbasetti Di Prun A, Fabbri E, Cetin I, Locatelli A, Consonni S, Rutolo S, Miotto E, Savasi V, Di Giminiani M, Cromi A, Binda S, Fiorina L, Furione M, Cassinelli G, Klersy C; CHILd Study Group. Prevalence, Outcome, and Prevention of Congenital Cytomegalovirus Infection in Neonates Born to Women With Preconception Immunity (CHILd Study). Clin Infect Dis. 2023 Feb 8;76(3):513-520. doi: 10.1093/cid/ciac482.

    PMID: 35717635DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Daniele Lilleri, MD

    Fondazione IRCCS Policlinico San Matteo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele Lilleri, MD

CONTACT

+39 0382 501501d.lilleri@smatteo.pv.it

Gabriela Cassinelli, PhD

CONTACT

+39 0382 502682g.cassinelli@smatteo.pv.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2019

First Posted

June 4, 2019

Study Start

September 4, 2017

Primary Completion

July 1, 2020

Study Completion

December 1, 2020

Last Updated

June 4, 2019

Record last verified: 2019-05

Locations

IT(12)