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

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ClinicalTrials.gov Identifier: NCT02710864
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Zhang, Xiamen University

Study Description
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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
Congenital Cytomegalovirus Infection

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1510 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 14 Days
Actual Study Start Date : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of cCMV infection in newborns [ Time Frame: up to 5 months ]

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

Biospecimen Retention:   Samples With DNA
saliva and urine samples of the newborns

Eligibility Criteria
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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710864


Locations
China, Fujian
Maternity and Child care of Huli District
Xiamen, Fujian, China, 361000
China, Henan
Maternity and Child care of Jiaxian County
Pingdingshan, Henan, China, 467100
Maternity and Child care of Xinmi City
Zhengzhou, Henan, China, 450000
Maternity and Child care of Zhongmu County
Zhengzhou, Henan, China, 451450
Sponsors and Collaborators
Jun Zhang
Investigators
Principal Investigator: Jun Zhang, Professor Xiamen University
More Information
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Responsible Party: Jun Zhang, Vice dean of School of Public Health,Xiamen University, Xiamen University
ClinicalTrials.gov Identifier: NCT02710864     History of Changes
Other Study ID Numbers: CMV-EPI-003
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jun Zhang, Xiamen University:
Cytomegalovirus

Additional relevant MeSH terms:
Infection
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases