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Clinical Trials/NCT05630898
NCT05630898
Not yet recruiting
Not Applicable

Congenital Cytomegalovirus: Prevalence in Buenos Aires City

Hospital de Niños R. Gutierrez de Buenos Aires3 sites in 1 country3,000 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Cytomegalovirus
Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Enrollment
3000
Locations
3
Primary Endpoint
prevalence of cCMV
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
December 30, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital de Niños R. Gutierrez de Buenos Aires
Responsible Party
Principal Investigator
Principal Investigator

Daniela Satragno, MD

MD

Hospital de Niños R. Gutierrez de Buenos Aires

Eligibility Criteria

Inclusion Criteria

  • Newborns between 1 and 21 days
  • informed consent

Exclusion Criteria

  • Lethal malformation

Outcomes

Primary Outcomes

prevalence of cCMV

Time Frame: 5 months

newborns positive for CMV

Secondary Outcomes

  • incidence of neurosensorial hearing loss during the 1° year of life(1 year)
  • incidence of visual impairments detected during the 1° year of life(1 year)

Study Sites (3)

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