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

May 1, 2018 updated by: Jun Zhang
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Maternity and Child care of Huli District
    • Henan
      • Pingdingshan, Henan, China, 467100
        • Maternity and Child care of Jiaxian County
      • Zhengzhou, Henan, China, 450000
        • Maternity and Child care of Xinmi City
      • Zhengzhou, Henan, China, 451450
        • Maternity and Child care of Zhongmu County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Neonates aged 0 to 14 days in MCHHs of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City, in China ,were recruited, after written informed consents provided by the parents.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of cCMV infection in newborns
Time Frame: up to 5 months
up to 5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the Kappa value of CMV prevalence between saliva and urine samples
Time Frame: up to 5 months
up to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Zhang

Investigators

  • Principal Investigator: Jun Zhang, Professor, Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 5, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMV-EPI-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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