Congenital Cytomegalovirus: Prevalence in Buenos Aires City (cCMV Prevalence) (cCMV)

November 18, 2022 updated by: Daniela Satragno, MD, Hospital de Niños R. Gutierrez de Buenos Aires

Congenital Cytomegalovirus: Prevalence in Buenos Aires City

The goal of this observational study is to recognise the prevalnce of congenital cytomegalovirus (cCMV) and to follow up positive babies until 12 months The main questions it aims to answer are: pevalence of cCMV, cCMV clinicals outcomes during the first year of life.

Participants will be screened with a salive swab for CMV DNA. Babies with positive results will be follow up for one year.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cytomegalovirus (CMV) is a frequent cause of congenital infection and a leading nongenetic cause of sensorineural hearing loss. In most infants with congenital CMV infection, clinical abnormalities do not manifest at birth; rather, the infection is asymptomatic. However, sensorineural hearing loss eventually develops in approximately 10 to 15% of CMV positive children.

The prevalence of congenital cytomegalovirus has been reported as 0·2% to 2·0% (average of 0·64%). There is not any publication of the prevalence of cCMV in Buenos Aires City. We aim the study to find the prevalence in this population Screening of newborns for CMV infection permit early identification of at-risk congenitally infected infants for purposes of targeted monitoring and intervention during critical stages of speech and language development.

Testing saliva via DNA detection of the virus through polymerase chain reaction testing (PCR) or rapid culture is shown to have a high sensitivity (>97%) and specificity (99%) for detecting congenital CMV infection.

Our objective is to describe the prevalence of cCMV using saliva specimens for PCR detection.

Secondary objectives includes describing prevalence of neurosensorial hearing loss and visual impairments during 1 year follow up.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1015
        • Clínica y Maternidad Suizo Argentina
        • Contact:
      • Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1246
        • Hospital Materno Infantil Ramón Sardá
        • Contact:
      • Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina, C1425
        • Hospital de Niños Ricardo Gutiérrez
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborns

Description

Inclusion Criteria:

  • Newborns between 1 and 21 days
  • informed consent

Exclusion Criteria:

  • Lethal malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of cCMV
Time Frame: 5 months
newborns positive for CMV
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of neurosensorial hearing loss during the 1° year of life
Time Frame: 1 year
fail Hearing test
1 year
incidence of visual impairments detected during the 1° year of life
Time Frame: 1 year
anormal eye exam
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Niños R. Gutierrez de Buenos Aires

Investigators

  • Principal Investigator: Daniela Satragno, MD, Hospital de Niños Ricardo Gutiérrez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

November 18, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNinosBuenosAires

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Cytomegalovirus

Clinical Trials on CMV PCR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe