UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019956 |
|---|---|
| Receipt number | R000023041 |
| Scientific Title | Nasal continuous positive airway pressure with bi-level mechanical ventilation at home |
| Date of disclosure of the study information | 2015/11/27 |
| Last modified on | 2015/11/27 14:51:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Nasal continuous positive airway pressure with bi-level mechanical ventilation at home
Acronym
Nasal continuous positive airway pressure with bi-level mechanical ventilation at home
Scientific Title
Nasal continuous positive airway pressure with bi-level mechanical ventilation at home
Scientific Title:Acronym
Nasal continuous positive airway pressure with bi-level mechanical ventilation at home
Region
| Japan |
Condition
Condition
tracheomalacia
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The nasal-CPAP therapy at home without having to enforce the tracheotomy for patients recieving CPAP therapy in the hospital
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To assess the presence or absence of depression breathing and torture -like facial expressions of children The records will be collected during a single outpatient visits a month
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The nasal-CPAP therapy of Kawaguchi fomula
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 | years-old | <= |
Age-upper limit
| 3 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients in the hospital with CPAP therapy
Key exclusion criteria
patients who can break away from CPAP
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Nakamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Comprehensive Perinatal Maternal and Child Medical Center
Zip code
Address
65,turumai-cho,syouwa-ku,nagoya city
TEL
052-741-2111
yukoichi@poem.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Nakamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Comprehensive Perinatal Maternal and Child Medical Center
Zip code
Address
65,turumai-cho,syouwa-ku,nagoya city
TEL
052-741-2111
Homepage URL
yukoichi@poem.ocn.ne.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 27 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2015 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023041
