UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013906 |
|---|---|
| Receipt number | 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 | 2020/04/10 22:09:36 |
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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 | 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, Japan
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
Maternal and Perinatal Center, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Neonatal Research Network
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 University
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
Completed
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=R000016176
