UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012689
Receipt number R000014822
Scientific Title High-dose erythropoietin therapy for the purpose of brain protection in neonatal hypoxic-ischemic encephalopathy
Date of disclosure of the study information 2013/12/25
Last modified on 2013/12/25 15:56:19

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Basic information

Public title

High-dose erythropoietin therapy for the purpose of brain protection in neonatal hypoxic-ischemic encephalopathy

Acronym

High-dose erythropoietin therapy for neonatal hypoxic-ischemic encephalopathy

Scientific Title

High-dose erythropoietin therapy for the purpose of brain protection in neonatal hypoxic-ischemic encephalopathy

Scientific Title:Acronym

High-dose erythropoietin therapy for neonatal hypoxic-ischemic encephalopathy

Region

Japan


Condition

Condition

Hypoxic-ischemic encephalopathy

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Neuroprotective effect of erythropoietin have been reported in recent years. The purpose of this study is to investigate whether the high-dose erythropoietin therapy in neonatal hypoxic-ischemic encephalopathy can reduce later brain injury.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

EEG, brain ultrasonography:neonatal period:
brain MRI:within 1 month,1year
blood exam(Hb,plt):day1,3,7,14,30
18 month:developmental test

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

Treatment

Type of intervention

Medicine

Interventions/Control_1

Five days injection of erythropoietin (2500 units / kg) in neonates with severe asphyxia.

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


Not applicable

Age-upper limit

1 years-old >=

Gender

Male and Female

Key inclusion criteria

The neonatal cases of severe asphyxia.
Apgar score at 5min 3>
umbilical cord blood,arterial-venous blood ph 7>,
Sarnat classification stage III,
aEEG higher voltage <5 microV

Key exclusion criteria

Congenital malformations,
chromosomal abnormalities

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi Hasegawa

Organization

Osaka Medical College Hospital

Division name

Pediatrics

Zip code


Address

2-7 Daigaku-mathi, Takatsuki-si, Osaka, Japan

TEL

0726831221

Email

ped082@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi Hasegawa

Organization

Osaka Medical College Hospital

Division name

Pediatrics

Zip code


Address

2-7 Daigaku-mathi, Takatsuki-si, Osaka, Japan

TEL

0726831221

Homepage URL


Email

ped082@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College

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

2013 Year 12 Month 25 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

2012 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 25 Day

Last modified on

2013 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014822


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name