UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002268 |
|---|---|
| Receipt number | R000002776 |
| Scientific Title | Progesterone replacement for prevention of adrenal insufficiency in extremely preterm infants |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2017/02/23 11:52:13 |
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Basic information
Public title
Progesterone replacement for prevention of adrenal insufficiency in extremely preterm infants
Acronym
Progesterone replacement in extremely preterm infants
Scientific Title
Progesterone replacement for prevention of adrenal insufficiency in extremely preterm infants
Scientific Title:Acronym
Progesterone replacement in extremely preterm infants
Region
| Japan |
Condition
Condition
adrenal insufficiency of prematurity
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of adrenal insufficiency of prematurity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of adrenal insufficiency of prematurity
Key secondary outcomes
Incidence of chronic lung disease
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
progesterone replacement
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 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
less than 28 gw
Key exclusion criteria
critical condition
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kusuda, Satoshi |
Organization
Tokyo Women's Medicla University
Division name
Maternal and Perinatal Center
Zip code
Address
8-1 Kawadacho, Shinjuku, Tokyo
TEL
03-5269-7344
kusuda-satoshi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kusuda |
Organization
Tokyo Women's Medical Center
Division name
Maternal and Perinatal Center
Zip code
Address
8-1 Kawadacho, Shinjuku, Tokyo
TEL
03-5269-7344
Homepage URL
kusuda-satoshi@umin.ac.jp
Sponsor or person
Institute
Maternal and Perinatal Center, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Maternal and Perinatal Center, Tokyo Women's Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
Maternal and Perinatal Center, Tokyo Women's Medical University
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
no protective effect of progesterone on late circulatory collapse in preterm infants.
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
Main results already published
Date of protocol fixation
| 2009 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 29 | Day |
Last modified on
| 2017 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002776
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
