UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016803 |
|---|---|
| Receipt number | 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 12:27:39 |
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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
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
kidokoro@med.nagoya.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019502
