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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032627
Receipt No. R000037203
Scientific Title Erythropoietin, Magnesium sulfate and Hypothermia for Hypoxic-Ischemic Encephalopathy
Date of disclosure of the study information 2018/05/18
Last modified on 2018/05/17

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Basic information
Public title Erythropoietin, Magnesium sulfate and Hypothermia for Hypoxic-Ischemic Encephalopathy
Acronym Erythropoietin, Magnesium sulfate and Hypothermia for Hypoxic-Ischemic Encephalopathy
Scientific Title Erythropoietin, Magnesium sulfate and Hypothermia for Hypoxic-Ischemic Encephalopathy
Scientific Title:Acronym Erythropoietin, Magnesium sulfate and Hypothermia for 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 To determine the feasibility and safety of erythropoietin and magnesium sulfate given in conjunction with hypothermia for hypoxicischemic encephalopathy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serious advverse evvents
Key secondary outcomes BP and HR at 0-7 days of age
Motality and morbidity at 0-7 days and 18 months of age
Neurodevelopmental outocome at 18 months of age

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Recombinant human erythropoietin 300 U/kg every other day for 2 weeks
Mugnesium sulfate 250mg/kg for 3 days
Hypothermia 33.5 degrees C for 72 hours
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
1 days-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network hypothermia trial.
Key exclusion criteria Exclusion criteria by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network hypothermia trial.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Ichiba
Organization Osaka City General Hospital
Division name Department of Neonatology
Zip code
Address 2-13-22 Miyakojimahondori, Miyakojimaku, Osaka 534-0021 JAPAN
TEL 0669291221
Email h-ichiba@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Ichiba
Organization Osaka City General Hospital
Division name Department of Neonatology
Zip code
Address 2-13-22 Miyakojimahondori, Miyakojimaku, Osaka 534-0021 JAPAN
TEL 0669291221
Homepage URL
Email h-ichiba@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City General Hospital
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 05 Month 18 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 Completed
Date of protocol fixation
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 05 Month 17 Day
Last modified on
2018 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037203

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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