Congenital Cytomegalovirus Infection Clinical Trial
| NCT number | NCT02710864 |
| Other study ID # | CMV-EPI-003 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2015 |
| Est. completion date | March 2016 |
| Verified date | May 2018 |
| Source | Xiamen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 1510 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 14 Days |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Maternity and Child care of Jiaxian County | Pingdingshan | Henan |
| China | Maternity and Child care of Huli District | Xiamen | Fujian |
| China | Maternity and Child care of Xinmi City | Zhengzhou | Henan |
| China | Maternity and Child care of Zhongmu County | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Jun Zhang |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of cCMV infection in newborns | up to 5 months | ||
| Secondary | the Kappa value of CMV prevalence between saliva and urine samples | up to 5 months |
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