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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038267
Receipt No. 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 2020/10/10

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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
Email 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
Email itoh@ncnp.go.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2020 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043621

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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