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
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
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
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
