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

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.

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Key information

Conditions

Congenital Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Maternity and Child care of Huli District, Xiamen, Fujian, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of cCMV infection in newborns

Time frame: up to 5 months

Secondary outcomes

the Kappa value of CMV prevalence between saliva and urine samples

Time frame: up to 5 months

Sponsors and collaborators

Lead sponsor

Jun Zhang

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Mar 17, 2016
Registry last updated: May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed