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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013906
Receipt No. R000016176
Scientific Title A Randomized Controlled Trial to Compare High-Flow Nasal Cannula with Nasal CPAP after Extubation in Preterm infants
Date of disclosure of the study information 2014/07/01
Last modified on 2015/05/13

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Basic information
Public title A Randomized Controlled Trial to Compare High-Flow Nasal Cannula with Nasal CPAP after Extubation in Preterm infants
Acronym HFNC Versus NCPAP for Extubated Preterm Infants
Scientific Title A Randomized Controlled Trial to Compare High-Flow Nasal Cannula with Nasal CPAP after Extubation in Preterm infants
Scientific Title:Acronym HFNC Versus NCPAP for Extubated Preterm Infants
Region
Japan

Condition
Condition neonatal respiratory disorders
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of High-Flow Nasal Cannula with those of Nasal CPAP in post extubated infants less than 34 gestational weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of re-intubation within 7 days after extubation
Key secondary outcomes The incidence of complications, tolerability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 High-Flow Nasal Cannula group
Interventions/Control_2 Nasal CPAP group
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
22 weeks-old <=
Age-upper limit
34 weeks-old >=
Gender Male and Female
Key inclusion criteria Preterm infants between 22 and 33 weeks of gestational age
Key exclusion criteria Chromosomal anomalies, Major congenital anomalies
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kusuda
Organization Tokyo Women's Medical University
Division name Maternal and Perinatal Center
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email kusuda.satoshi@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Uchiyama
Organization Tokyo Women's Medical University
Division name Maternal and Perinatal Center
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email uchiyama.atsushi@twmu.ac.jp

Sponsor
Institute Maternal and Perinatal Center, Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Fisher & Paykel Healthcare Japan
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
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
2014 Year 07 Month 01 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
2014 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 10 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
2014 Year 05 Month 08 Day
Last modified on
2015 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016176

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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