A Cross-sectional Study of Congenital Cytomegalovirus Infection in Newborns in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Cytomegalovirus Infection
- Sponsor
- Jun Zhang
- Enrollment
- 1510
- Locations
- 4
- Primary Endpoint
- Number of cCMV infection in newborns
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jun Zhang
Vice dean of School of Public Health,Xiamen University
Xiamen University
Eligibility Criteria
Inclusion Criteria
- •Neonates aged 0 to 14 days
- •Neonates delivered in MCHHs of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City
Exclusion Criteria
- •the parents of neonates not comply with our study
Outcomes
Primary Outcomes
Number of cCMV infection in newborns
Time Frame: up to 5 months
Secondary Outcomes
- the Kappa value of CMV prevalence between saliva and urine samples(up to 5 months)