UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025991 |
|---|---|
| Receipt number | 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 | 2022/08/09 11:32:56 |
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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
| 1 | days-old | <= |
Age-upper limit
| 2 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Preterm infants with less than 37 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 | Satoru |
| Middle name | |
| Last name | Takeshita |
Organization
Aichi Medical University
Division name
Perinatal and Neonatal Center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
satorut@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Takeshita |
Organization
Aichi Medical University
Division name
Perinatal and Neonatal Center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
satorut@aichi-med-u.ac.jp
Sponsor or person
Institute
Perinatal and Neonatal Center, Aichi Medical University
Institute
Department
Personal name
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
Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute-City, Aichi, Japan
Tel
0561-62-3311
satorut@aichi-med-u.ac.jp
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
https://www.nature.com/articles/s41390-022-02107-7
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41390-022-02107-7
Number of participants that the trial has enrolled
203
Results
Thrombocytopenia in SGA infants was found to be due to decreased expression of thrombopoietin. These findings are presumed to be due to liver dysmature caused by chronic hypoxia in utero and add to our understanding of the etiology of thrombocytopenia in SGA infants. The findings also suggest that TPO receptor agonists would be effective as novel therapeutic agents.
Results date posted
| 2022 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Preterm infants admitted to the Department of Perinatal and Neonatal Medicine at Aichi Medical University Hospital.
Participant flow
Follow-up was completed.
Adverse events
None.
Outcome measures
Already mentioned in the paper.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029876
