Clinical trial NCT05630898: Congenital Cytomegalovirus: Prevalence in Buenos Aires City (cCMV Prevalence)
Official title: Congenital Cytomegalovirus: Prevalence in Buenos Aires City
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Cytomegalovirus
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns

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.

Eligibility criteria: Inclusion Criteria:

* Newborns between 1 and 21 days
* informed consent

Exclusion Criteria:

* Lethal malformation

Primary outcomes:
measure: prevalence of cCMV
timeFrame: 5 months
Secondary outcomes:
measure: incidence of neurosensorial hearing loss during the 1° year of life
timeFrame: 1 year
measure: incidence of visual impairments detected during the 1° year of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Ciudad Autonoma De Buenos Aires
country: Argentina
facility: Clinica y maternidad Suizo Argentina
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aires
country: Argentina
facility: Hospital Materno Infantil Ramón Sardá
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aires
country: Argentina
facility: Hospital de Niños Ricardo Gutiérrez
state: Buenos Aires
Study officials:
affiliation: Hospital de Niños Ricardo Gutierrez
name: Daniela Satragno, MD
role: PRINCIPAL_INVESTIGATOR
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