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临床试验/NCT05630898
NCT05630898尚未招募不适用

Congenital Cytomegalovirus: Prevalence in Buenos Aires City

Hospital de Niños R. Gutierrez de Buenos Aires3 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
3,000
试验地点
3
主要终点
prevalence of cCMV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Day 至 21 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Newborns between 1 and 21 days
  • informed consent

排除标准

  • Lethal malformation

结局指标

主要结局

prevalence of cCMV

时间窗: 5 months

newborns positive for CMV

次要结局

  • 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)

研究者

发起方
Hospital de Niños R. Gutierrez de Buenos Aires
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Satragno, MD

MD

Hospital de Niños R. Gutierrez de Buenos Aires

研究点 (3)

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