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

Sponsor
Jun Zhang (Other)
Overall Status
Completed
CT.gov ID
NCT02710864
Collaborator
(none)
1,510
Enrollment
4
Locations
14
Actual Duration (Months)
377.5
Patients Per Site
27
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1510 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Mar 1, 2016
    Actual Study Completion Date :
    Mar 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Number of cCMV infection in newborns [up to 5 months]

    Secondary Outcome Measures

    1. the Kappa value of CMV prevalence between saliva and urine samples [up to 5 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 14 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maternity and Child care of Huli District Xiamen Fujian China 361000
    2 Maternity and Child care of Jiaxian County Pingdingshan Henan China 467100
    3 Maternity and Child care of Xinmi City Zhengzhou Henan China 450000
    4 Maternity and Child care of Zhongmu County Zhengzhou Henan China 451450

    Sponsors and Collaborators

    • Jun Zhang

    Investigators

    • Principal Investigator: Jun Zhang, Professor, Xiamen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Zhang, Vice dean of School of Public Health,Xiamen University, Xiamen University
    ClinicalTrials.gov Identifier:
    NCT02710864
    Other Study ID Numbers:
    • CMV-EPI-003
    First Posted:
    Mar 17, 2016
    Last Update Posted:
    May 7, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Jun Zhang, Vice dean of School of Public Health,Xiamen University, Xiamen University
    Cytomegalovirus
    Additional relevant MeSH terms:
    Infections
    Cytomegalovirus Infections

    Study Results

    No Results Posted as of May 7, 2018