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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019956
Receipt No. 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

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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
Email 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
Email yukoichi@poem.ocn.ne.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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