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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013907
Receipt No. R000016212
Scientific Title A Randomized Controlled Trial to Compare High-Flow Nasal Cannula with Nasal CPAP in Infants More Than 34 Weeks of Gestational Age with Respiratory Disorders
Date of disclosure of the study information 2014/07/01
Last modified on 2020/04/10

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Basic information
Public title A Randomized Controlled Trial to Compare High-Flow Nasal Cannula
with Nasal CPAP in Infants More Than 34 Weeks of Gestational Age
with Respiratory Disorders
Acronym HFNC Versus NCPAP for Respiratory Disorders in Infants
More Than 34 Gestational Weeks
Scientific Title A Randomized Controlled Trial to Compare High-Flow Nasal Cannula
with Nasal CPAP in Infants More Than 34 Weeks of Gestational Age
with Respiratory Disorders
Scientific Title:Acronym HFNC Versus NCPAP for Respiratory Disorders in Infants
More Than 34 Gestational Weeks
Region
Japan

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

Objectives
Narrative objectives1 To comare HFNC with NCPAP in infants with respiratory disorders more than 34 weeks of gestational age
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of intubation within 72 hours after starting to use each device
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 HFNC group NCPAP group
Interventions/Control_2 NCPAP 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
34 weeks-old <=
Age-upper limit
42 weeks-old >
Gender Male and Female
Key inclusion criteria New born infants with respiratory disorders more than 34 weeks of gestational age
Key exclusion criteria Chromosomal anomalies, Congenital anomalies
Target sample size 260

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Kusuda
Organization Tokyo Women's Medical University
Division name Maternal and Perinatal Center
Zip code 162-0866
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email kusuda.satoshi@twmu.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Uchiyama
Organization Tokai University School of Medicine
Division name Department of Pediatrics,
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa, Japan
TEL 0463-93-1121
Homepage URL
Email uchiyama.atsushi@tsc.u-tokai.ac.jp

Sponsor
Institute Tokyo Women's Medical Univerity
Institute
Department

Funding Source
Organization Neonatal Research Net Work
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 Tokyo Women's Medical Univerity
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
Tel 03-3353-8111
Email ohta.megumi@twmu.ac.jp

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 Terminated
Date of protocol fixation
2014 Year 05 Month 10 Day
Date of IRB
2014 Year 09 Month 11 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
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
2020 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016212

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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