A Cross-sectional Study of Congenital Cytomegalovirus Inf... | NCT02710864

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

NCT02710864

Sponsor

Jun Zhang

Status

Completed

Last Update Posted

May 7, 2018Actual

Enrollment

1,510Actual

Phase

Not provided

Conditions

Congenital Cytomegalovirus Infection

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Mar 5, 2016

First Submission Date that Met QC Criteria

Mar 11, 2016

First Posted Date

Mar 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2018

Last Update Posted Date

May 7, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

14 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,510Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Days

Standard Ages

Child

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun Zhang, Professor	Xiamen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternity and Child care of Huli District		Xiamen	Fujian	361000	China
Maternity and Child care of Jiaxian County

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003586	Cytomegalovirus Infections

Ancestor Terms

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided