UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059688 |
|---|---|
| Receipt number | R000067629 |
| Scientific Title | Evaluation of the Usefulness of Short-Duration Brain MRI for Detecting Intracranial Lesions During the Perioperative Period of Neonatal and Early-Infant Open-Heart Surgery |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 18:16:16 |
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Basic information
Public title
ORION Study: Open-heart perioperative Rapid MRI Of Neonates/infants
Acronym
ORION Study
Scientific Title
Evaluation of the Usefulness of Short-Duration Brain MRI for Detecting Intracranial Lesions During the Perioperative Period of Neonatal and Early-Infant Open-Heart Surgery
Scientific Title:Acronym
ORION Study
Region
| Japan |
Condition
Condition
Congenital heart disease
Classification by specialty
| Cardiology | Pediatrics | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Diagnostic Performance and Clinical Usefulness of Short-Duration Brain MRI in Detecting Intracranial Lesions During the Perioperative Period of Neonatal Open-Heart Surgery with Cardiopulmonary Bypass
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity of short-duration brain MRI for detecting lesions identified on standard-protocol MRI
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
| Medicine |
Interventions/Control_1
Sedation for Short-duration brain MRI protocol
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 | days-old | <= |
Age-upper limit
| 6 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Neonates and infants eligible for brain MRI during the perioperative period of open-heart surgery performed at our institution between October 20, 2025, and March 31, 2027.
Key exclusion criteria
Patients in whom sedation for brain MRI is considered difficult.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Takahara |
Organization
Miyagi Children's Hospital
Division name
Cardiovascular Surgery
Zip code
989-3126
Address
4-3-17 Ochiai, Aoba-ku, Sendai City, Miyagi Prefecture 989-3126, Japan
TEL
022-391-5111
takahara-s-mch@miyagi-children.or.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Niwano |
Organization
Miyagi Children's Hospital
Division name
Cardiovascular Surgery
Zip code
989-3126
Address
4-3-17 Ochiai, Aoba-ku, Sendai City, Miyagi Prefecture 989-3126, Japan
TEL
022-391-5111
Homepage URL
niwano.haruki.710@gmail.com
Sponsor or person
Institute
Miyagi Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Miyagi Children's Hospital
Address
4-3-17 Ochiai, Aoba-ku, Sendai City, Miyagi Prefecture 989-3126, Japan
Tel
022-391-5111
crmo@miyagi-children.or.jp
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
地方独立行政法人 宮城県立こども病院(宮城県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067629
