Clinical Trial: A Cross-sectional Study of Congenital Cytomegalovirus Infection in Newborns in China

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title:

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 Summary: 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.
Sponsor: Jun Zhang

Current Primary Outcome: Number of cCMV infection in newborns [ Time Frame: up to 5 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: the Kappa value of CMV prevalence between saliva and urine samples [ Time Frame: up to 5 months ]

Original Secondary Outcome: Same as current

Information By: Xiamen University

Dates:
Date Received: March 5, 2016
Date Started: June 2015
Date Completion: July 2016
Last Updated: March 11, 2016
Last Verified: February 2016