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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02710864
Other study ID # CMV-EPI-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date March 2016

Study information

Verified date May 2018
Source Xiamen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 1510
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 14 Days
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Maternity and Child care of Jiaxian County Pingdingshan Henan
China Maternity and Child care of Huli District Xiamen Fujian
China Maternity and Child care of Xinmi City Zhengzhou Henan
China Maternity and Child care of Zhongmu County Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Jun Zhang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of cCMV infection in newborns up to 5 months
Secondary the Kappa value of CMV prevalence between saliva and urine samples up to 5 months
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