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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016803
Receipt No. R000019502
Scientific Title Elucidation of structural and functional alterations of the preterm brain using advanced MR imaging
Date of disclosure of the study information 2015/03/17
Last modified on 2015/03/15

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Basic information
Public title Elucidation of structural and functional alterations of the preterm brain using advanced MR imaging
Acronym Elucidation of alterations of the preterm brain using MRI
Scientific Title Elucidation of structural and functional alterations of the preterm brain using advanced MR imaging
Scientific Title:Acronym Elucidation of alterations of the preterm brain using MRI
Region
Japan

Condition
Condition preterm infants
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) Elucidation of brain structure of the preter infant with cognitive or developmental disability.
2) Exploration of the early MR marker which predicts cognitive or divelopmental disability at age 6 in preterm infants.
Basic objectives2 Others
Basic objectives -Others To explore the early MR marker for early intervention.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brain MR images related to cognitive or developmental disability.
Key secondary outcomes

Base
Study type

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 Brain MRI is performed.
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
7 years-old >=
Gender Male and Female
Key inclusion criteria Preterm infants whose gestational age at birth is 34 weeks or younger.
Key exclusion criteria Contraindication of MRI
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name hiroyuki_kidokoro
Organization Nagoya University Hospital
Division name Pediatrics
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-741-2111
Email kidokoro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name hiroyuki_kidokoro
Organization Nagoya Univeristy Graduate School of Medicine
Division name kido
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-1901
Homepage URL
Email kidokoro@med.nagoya.ac.jp

Sponsor
Institute Department of Pediatrics, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization KAKEN
Organization
Division
Category of Funding Organization
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
2015 Year 03 Month 17 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
2015 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 15 Day
Last modified on
2015 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019502

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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