NCT05630898

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

Congenital Cytomegalovirus: Prevalence in Buenos Aires City

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires · Academic / Other
• Sex: All
• Age: 1 Day – 21 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Cytomegalovirus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CMV PCR	Saliva CMV PCR

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-09-30
• Completion: 2024-12-30
• First posted: 2022-11-30
• Last updated: 2022-11-30

Locations

3 sites across 1 country: Argentina