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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02710864

Enrollment

1510

Registered

2016-03-17

Start date

2015-01-31

Completion date

2016-03-31

Last updated

2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Cytomegalovirus Infection

Keywords

Cytomegalovirus

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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

No minimum to 14 Days

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

Design outcomes

Primary

Measure	Time frame
Number of cCMV infection in newborns	up to 5 months

Secondary

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

Countries

China

Outcome results