UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007035 |
|---|---|
| Receipt number | R000007649 |
| Scientific Title | Distribution of difference between spontaneous breath and mechanical ventilation in infant |
| Date of disclosure of the study information | 2012/12/11 |
| Last modified on | 2014/07/10 12:50:50 |
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Basic information
Public title
Distribution of difference between spontaneous breath and mechanical ventilation in infant
Acronym
Distribution of difference between spontaneous breath and mechanical ventilation in infant
Scientific Title
Distribution of difference between spontaneous breath and mechanical ventilation in infant
Scientific Title:Acronym
Distribution of difference between spontaneous breath and mechanical ventilation in infant
Region
| Japan |
Condition
Condition
Respiratory failure
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find distribution of difference between spontaneous breath and mechanical ventilation in infant
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To find distribution of difference between spontaneous breath and mechanical ventilation in infant.
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
| Not applicable |
Age-upper limit
| 1 | months-old | > |
Gender
Male and Female
Key inclusion criteria
The infant whose body weigt >=750g,with Mechanical ventilation
Key exclusion criteria
Thoracocyllosis
Dysplasia of air way, bronchi and lung.
Significant leak under normal ventilation (>30%)
positive end expiratory pressure (peep)>7cmH20
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tutomu Kondo |
Organization
Tokyo womens medical university
Division name
yachiyo medical center
Zip code
Address
yachiyosi oowadasinden 477-96
TEL
047-450-6000
yoh_omura@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yo omura |
Organization
Tokyo womens medical university
Division name
yachiyo medical center
Zip code
Address
yachiyosi oowadasinden 477-96
TEL
047-450-6000
Homepage URL
yoh_omura@hotmail.com
Sponsor or person
Institute
Tokyo womens medical university
Institute
Department
Personal name
Funding Source
Organization
Tokyo womens medical university
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 11 | 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
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
Observing the movement of the chest wall with a laser due to the breathing pattern of positive airway pressure ventilation and spontaneous breathing.
Management information
Registered date
| 2012 | Year | 01 | Month | 07 | Day |
Last modified on
| 2014 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007649
| 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 |
