UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006263 |
|---|---|
| Receipt number | R000007414 |
| Scientific Title | Effect of Diffuse-Chorioamniotic-Hemosiderosis on the development of chronic lung disease in premature infants |
| Date of disclosure of the study information | 2011/09/05 |
| Last modified on | 2015/10/28 10:08:06 |
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Basic information
Public title
Effect of Diffuse-Chorioamniotic-Hemosiderosis on the development of chronic lung disease in premature infants
Acronym
Diffuse-Chorioamniotic-Hemosiderosis and chronic lung disease in premature infants
Scientific Title
Effect of Diffuse-Chorioamniotic-Hemosiderosis on the development of chronic lung disease in premature infants
Scientific Title:Acronym
Diffuse-Chorioamniotic-Hemosiderosis and chronic lung disease in premature infants
Region
| Japan |
Condition
Condition
diffuse chorioamniotic hemosiderosis
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effect on the development of chronic lung disease in premature infants
Basic objectives2
Others
Basic objectives -Others
pathology of placenta
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
severity of chronic lung disease in premature infants
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 | weeks-old | <= |
Age-upper limit
| 0 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
birth weight under 1,500g
Key exclusion criteria
chromosome aberration
metabolic disorder
multiple anomaly
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Watanabe |
Organization
Tohoku university hospital
Division name
neonatal center for perinatal medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL
022-717-7287
tatsu-w@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Watanabe |
Organization
Tohoku university hospital
Division name
neonatal center for perinatal medicune
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574 Japan
TEL
022-717-7287
Homepage URL
tatsu-w@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
national institute of public health
Organization
Division
Category of Funding Organization
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
東北大学病院（宮城県）、仙台赤十字病院（宮城県）、宮城県立こども病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
lung injury of premature infants before birth
pathology of placenta
clinical characteristic of chronic lung disease in premature infants
Management information
Registered date
| 2011 | Year | 08 | Month | 31 | Day |
Last modified on
| 2015 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007414
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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