UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032627
Receipt number 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 15:00:36

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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 or person

Institute

Osaka City General Hospital

Institute

Department

Personal name



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

Value
https://center6.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