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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025991
Receipt No. R000029876
Scientific Title Research on thrombopoiesis of preterm infants focusing on thrombopoietin
Date of disclosure of the study information 2017/02/03
Last modified on 2017/02/03

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Basic information
Public title Research on thrombopoiesis of preterm infants focusing on thrombopoietin
Acronym Research on thrombopoiesis of preterm infants
Scientific Title Research on thrombopoiesis of preterm infants focusing on thrombopoietin
Scientific Title:Acronym Research on thrombopoiesis of preterm infants
Region
Japan

Condition
Condition neonatal thrombocytopenia
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The research is aimed to elucidate a mechanizm of thrombopoisis in premature infants by measuring thrombopoietin and immature platelet fragment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate blood examination data such as platelet count, thrombopoietin and immature platelet fragment birth 0 to 2 days.
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
0 days-old <=
Age-upper limit
2 days-old >=
Gender Male and Female
Key inclusion criteria Preterm infants with less than 34 gestational weeks hospitalized at NICU.
Key exclusion criteria Infants with congenital anomalad or severe neonatal asphyxia and infants who were done transfusion therapy.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Takeshita
Organization Aichi Medical University
Division name Perinatal and Neonatal Center
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561-62-3311
Email satorut@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Takeshita
Organization Aichi Medical University
Division name Perinatal and Neonatal Center
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561-62-3311
Homepage URL
Email satorut@aichi-med-u.ac.jp

Sponsor
Institute Perinatal and Neonatal Center, Aichi Medical University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
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
2017 Year 02 Month 03 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
2017 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None.

Management information
Registered date
2017 Year 02 Month 03 Day
Last modified on
2017 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029876

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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