UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018983 |
|---|---|
| Receipt number | R000021932 |
| Scientific Title | Effective and safe use of heated humified high flow nasal cannula in neonates. |
| Date of disclosure of the study information | 2015/09/28 |
| Last modified on | 2016/03/23 19:22:53 |
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Basic information
Public title
Effective and safe use of heated humified high flow nasal cannula in neonates.
Acronym
Effective and safe use of heated humified high flow nasal cannula in neonates.
Scientific Title
Effective and safe use of heated humified high flow nasal cannula in neonates.
Scientific Title:Acronym
Effective and safe use of heated humified high flow nasal cannula in neonates.
Region
| Japan |
Condition
Condition
neonatal respiratory disorders
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety between High-Flow Nasal Cannula and Nasal CPAP in infants with neonatal respiratory disorders over 28 gestational weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of respiratory acidosis and hypercapnia 1 hour after intervention.
Key secondary outcomes
Improvement rate of oxygenation 1 hour after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
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
| 28 | weeks-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- infants over 28 gestational weeks and birth weight over 1000g
- infants with neonatal respiratory disorder, who does not respond to initial nasal CPAP therapy
- infants who do not have indication of intubation
Key exclusion criteria
- infants intubated at hospitalization
- infants with nasal, oral or airway anomaly
- infants with air leak at hospitalization
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuko Taki |
Organization
Tokyo Medical and Dental University
Division name
Pediatrics
Zip code
Address
1-5-45 Yushima Bunkyo Tokyo
TEL
03-3813-6111
ataki.ped@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo AOKI |
Organization
Tokyo Medical and Dental University
Division name
Pediatrics
Zip code
Address
1-5-45 Yushima Bunkyo Tokyo
TEL
03-3813-6111
Homepage URL
ronron81818@gmail.com
Sponsor or person
Institute
Tokyo Medical and Dental University
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 09 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | 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 | 09 | Month | 11 | Day |
Last modified on
| 2016 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021932
