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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002125
Receipt No. 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

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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
Obsterics 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
Email

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
Email

Sponsor
Institute Kobe University Graduate School of Medicine, department of Obstetrics and Gynecology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002594

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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