UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002125 |
|---|---|
| Receipt number | R000002594 |
| Scientific Title | establishment of screenig for congenital cytomegalovirus infection in newborns and analysis of clinical features of infected newborns |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2009/06/26 16:05:42 |
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Basic information
Public title
establishment of screenig for congenital cytomegalovirus infection in newborns and analysis of clinical features of infected newborns
Acronym
screening of cytomegalovirus infection in newborns and analysis of clinical features of infected newborns
Scientific Title
establishment of screenig for congenital cytomegalovirus infection in newborns and analysis of clinical features of infected newborns
Scientific Title:Acronym
screening of cytomegalovirus infection in newborns and analysis of clinical features of infected newborns
Region
| Japan |
Condition
Condition
newborns
Classification by specialty
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
establishment of the screening system for CCMVI newborns and analysis of clinical features of infected newborns
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
effecicacy of screenig system for CCMVI in newborns
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
measurement of CMV mRNA in the urine and blood of newborns
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | weeks-old | <= |
Age-upper limit
| 2 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
newborns who are positive for CMV mRNA in the urine and blood
Key exclusion criteria
newborns who are negative for CMV mRNA in the urine and blood
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mayumi Morizane |
Organization
Kobe University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
7-5-1 Kusunoki-Cho Chuo-Ku, Kobe, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Graduate School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
TEL
078-382-6005
Homepage URL
Sponsor or person
Institute
Kobe University Graduate School of Medicine, department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
no fund
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 26 | Day |
Last modified on
| 2009 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002594
