UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013907 |
|---|---|
| Receipt number | 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 22:20:55 |
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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
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
uchiyama.atsushi@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical Univerity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016212
