A Cross-sectional Study of Congenital Cytomegalovirus Infection in Newborns in China
- Conditions
- Congenital Cytomegalovirus Infection
- Registration Number
- NCT02710864
- Lead Sponsor
- Jun Zhang
- Brief Summary
The primary objectives of this study were to evaluate the incidence of congenital CMV infection in neonates, and assess the concordance of detecting congenital cytomegalovirus (CMV) infection in neonatal saliva and urine samples.
- Detailed Description
This Cross-sectional study was conducted to recruit neonates less than 14 days old delivered in Maternal and Child Health Hospitals (MCHHs) of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City, in China, from June 2015 to June 2016. The aim of this study is to enroll \~1800 neonates, and collect their saliva and urine samples which will be tested the CMV DNA by using real-time PCR.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1510
- Neonates aged 0 to 14 days
- Neonates delivered in MCHHs of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City
- the parents of neonates not comply with our study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of cCMV infection in newborns up to 5 months
- Secondary Outcome Measures
Name Time Method the Kappa value of CMV prevalence between saliva and urine samples up to 5 months
Trial Locations
- Locations (4)
Maternity and Child care of Huli District
🇨🇳Xiamen, Fujian, China
Maternity and Child care of Zhongmu County
🇨🇳Zhengzhou, Henan, China
Maternity and Child care of Jiaxian County
🇨🇳Pingdingshan, Henan, China
Maternity and Child care of Xinmi City
🇨🇳Zhengzhou, Henan, China