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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018467
Receipt No. R000021241
Scientific Title REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION DETECTION OF CONGENITAL RUBELLA INFECTION IN INFANTS USING SALIVA
Date of disclosure of the study information 2015/07/29
Last modified on 2015/07/29

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Basic information
Public title REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION DETECTION OF CONGENITAL RUBELLA INFECTION IN INFANTS USING SALIVA
Acronym REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION DETECTION OF CONGENITAL RUBELLA INFECTION IN INFANTS USING SALIVA
Scientific Title REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION DETECTION OF CONGENITAL RUBELLA INFECTION IN INFANTS USING SALIVA
Scientific Title:Acronym REAL-TIME REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION DETECTION OF CONGENITAL RUBELLA INFECTION IN INFANTS USING SALIVA
Region
Japan

Condition
Condition Congenital rubella infection
Classification by specialty
Infectious disease Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We therefore investigated the incidence of aCRI in infants in Tokyo by screening saliva samples for the rubella virus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Positive result of real-time PCR for rubella virus in infant's saliva
Key secondary outcomes Their mothers had caught rubella, and taken rubella vaccine, and exposed a rubella patient

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Saliva test on infant
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

Not applicable
Age-upper limit
2 months-old >
Gender Male and Female
Key inclusion criteria All infants who were born in the hospitals, or visit to these
Key exclusion criteria Subject who rejected to join in this study, or
who had been confirmed as rubella infection by amniotic fluid test, or
who had fever or rash if acute rubella infection had been not ruled out
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Yamamoto
Organization National Center for Global Health and Medicine
Division name Disease control and prevention center
Zip code
Address 1-21-1 Toyama, Shinjuku-ku
TEL +81332027181
Email nicepoko@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kei Yamamoto
Organization National Center for Global Health and Medicine
Division name Disease control and prevention center
Zip code
Address 1-21-1 Toyama, Shinjuku-ku
TEL +81332027181
Homepage URL
Email nicepoko@gmail.com

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Japan Foundation for Pediatric Research
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Pediatrics, National Center for Global Health and Medicine
Karugamo Clinic
Hosobe Clinic of Pediatrics
Matsudaira Clinic of Pediatrics
Wada Clinic of Pediatrics
Department of Pediatrics, Kawakita General
Hospital
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 独立行政法人国立国際医療研究センター病院(東京都)
かるがもクリニック(東京都)
細部小児科クリニック(東京都)
松平小児科(東京都)
和田小児科医院(東京都)
河北総合病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Of 213 enrolled infants, data were obtained from 195 (96 males). Their median age was 6 days (interquartile range [IQR]: 5 to 31 days) and their median gestation week (n=181) was 39.4 (IQR 38.3 to 40.1).
Sufficient volume (>200 uL) was obtained from 117 samples, and 78 samples had small volumes (100 to 200 uL, n = 41; 50 to 100 uL, n = 19; <50 uL, n = 18). All PCR tests were negative.
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 Completed
Date of protocol fixation
2014 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 04 Month 20 Day
Date trial data considered complete
2015 Year 05 Month 18 Day
Date analysis concluded

Other
Other related information Median age of mother was 34 years (IQR 30-37 years, n = 194). Of them, 90 mothers describe antibody titers of rubella (Hemagglutination Inhibition Test) during this pregnancy. Twenty nine mothers should receive rubella vaccine after delivery (2 had less than 1:8, 27 had 1:8 to 16).
Sixty nine mothers had a history of rubella infection. Of them, 2 mothers were diagnosed as rubella infection during this pregnancy.

Management information
Registered date
2015 Year 07 Month 29 Day
Last modified on
2015 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021241

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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