NCT02710864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

March 5, 2016

Last Update Submit

May 1, 2018

Conditions

Congenital Cytomegalovirus Infection

Keywords

Cytomegalovirus

Outcome Measures

Primary Outcomes (1)

  • Number of cCMV infection in newborns

    up to 5 months

Secondary Outcomes (1)

  • the Kappa value of CMV prevalence between saliva and urine samples

    up to 5 months

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Neonates aged 0 to 14 days
  • Neonates delivered in MCHHs of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City

You may not qualify if:

  • the parents of neonates not comply with our study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Maternity and Child care of Huli District

Xiamen, Fujian, 361000, China

Location

Maternity and Child care of Jiaxian County

Pingdingshan, Henan, 467100, China

Location

Maternity and Child care of Xinmi City

Zhengzhou, Henan, 450000, China

Location

Maternity and Child care of Zhongmu County

Zhengzhou, Henan, 451450, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva and urine samples of the newborns

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Jun Zhang, Professor

    Xiamen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice dean of School of Public Health,Xiamen University

Study Record Dates

First Submitted

March 5, 2016

First Posted

March 17, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations

CN(4)