UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038267 |
|---|---|
| Receipt number | R000043621 |
| Scientific Title | Cohort-study of a novel biomarker for neonatal hypoxic-ischemic encephalopathy |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2023/10/12 13:30:15 |
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Basic information
Public title
Clinical study for severity of neonatal hypoxic-ischemic encephalopathy
Acronym
Clinical study for neonatal hypoxic-ischemic encephalopathy
Scientific Title
Cohort-study of a novel biomarker for neonatal hypoxic-ischemic encephalopathy
Scientific Title:Acronym
Multicenter cohort-study for neonatal hypoxic-ischemic encephalopathy
Region
| Japan |
Condition
Condition
neonatal hypoxic-ischemic encephalopathy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of sLOX-1 cut-off value for severity of neonatal hypoxic-ischemic encephalopathy
Basic objectives2
Others
Basic objectives -Others
Validation of sLOX-1 cut-off value for severity of neonatal hypoxic-ischemic encephalopathy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
sLOX-1 cut-off value for severity of neonatal hypoxic-ischemic encephalopathy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1460 | days-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with neonatal hypoxic-ischemic encephalopathy.
1) acidemia (less than 7 of pH or more than 16 of base excess), derived with umbilical or autologous artery.
2) perinatal emergency events (ex. premature separation) and severe asphyxia.
1) or 2).
2. Control.
neonates without hypoxic-ischemic encephalopathy.
Key exclusion criteria
1. Patients with neonatal hypoxic-ischemic encephalopathy,
accompanied with anomalies, brain malformation, genetic diseases, metabolic disorders and congenital infections.
2. Controls, accompanied with anomalies, brain malformation, genetic diseases, metabolic disorders and congenital infections.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Itoh |
Organization
National Center of Neurology and Psychiatry
Division name
Mental Retardation and Birth Defect Research
Zip code
187-8502
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo, Japan
TEL
042-341-2712-5823
itoh@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Itoh |
Organization
National Center of Neurology and Psychiatry
Division name
Mental Retardation and Birth Defect Research
Zip code
187-8502
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo, Japan
TEL
042-341-2712-5823
Homepage URL
itoh@ncnp.go.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of National Center of Neurology and Psychiatry
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo, Japan
Tel
042-341-2712-7828
rinrijimu@ncnp.go.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 15 | 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
191
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We measure sLOX-1 value of participants' bloods at NICU admission. We analyze correlation between the severity and clinical data of neonatal hypoxic-ischemic encephalopathy and controls and those sLOX-1 values. Then, we set a cut-off value of sLOX-1 for decision of the severity.
Management information
Registered date
| 2019 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
