UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002613 |
|---|---|
| Receipt number | R000003188 |
| Scientific Title | Hypoxic gas therapy using nitrogen in congenital heart disease with increased pulmonary blood flow |
| Date of disclosure of the study information | 2009/10/10 |
| Last modified on | 2009/10/09 22:21:07 |
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Basic information
Public title
Hypoxic gas therapy using nitrogen in congenital heart disease with increased pulmonary blood flow
Acronym
Hypoxic gas therapy using nitrogen in congenital heart disease with increased pulmonary blood flow
Scientific Title
Hypoxic gas therapy using nitrogen in congenital heart disease with increased pulmonary blood flow
Scientific Title:Acronym
Hypoxic gas therapy using nitrogen in congenital heart disease with increased pulmonary blood flow
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
investigation of efficacy
Basic objectives2
Others
Basic objectives -Others
investigation of safety
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
alive or dead
Key secondary outcomes
side effects
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 | months-old | <= |
Age-upper limit
| 1 | months-old | > |
Gender
Male and Female
Key inclusion criteria
congenital heart disease with increased pulmonary blood flow
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Muneo Yoshibayashi |
Organization
Nara Hospital, Kinki University School of Medicine
Division name
Pediatrics
Zip code
Address
1248-1,Otoda-cho.Ikoma
TEL
0743-77-0880
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Muneo Yoshibayashi |
Organization
Nara Hospital, Kinki University School of Medicine
Division name
Pediatrics
Zip code
Address
1248-1,Otoda-cho.Ikoma
TEL
0743-77-0880
Homepage URL
muneo@nara.med.kindai.ac.jp
Sponsor or person
Institute
Nara Hospital, Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
近畿大学医学部奈良病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 10 | 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
| 2009 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
none
Management information
Registered date
| 2009 | Year | 10 | Month | 09 | Day |
Last modified on
| 2009 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003188
