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

NCT ID: NCT02710864

Last Updated: 2018-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1510 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Congenital Cytomegalovirus Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jun Zhang

OTHER

Sponsor Role lead

Responsible Party

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Jun Zhang

Vice dean of School of Public Health,Xiamen University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jun Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Xiamen University

Locations

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Maternity and Child care of Huli District

Xiamen, Fujian, China

Site Status

Maternity and Child care of Jiaxian County

Pingdingshan, Henan, China

Site Status

Maternity and Child care of Xinmi City

Zhengzhou, Henan, China

Site Status

Maternity and Child care of Zhongmu County

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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CMV-EPI-003

Identifier Type: -

Identifier Source: org_study_id

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