UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020821 |
|---|---|
| Receipt number | R000024031 |
| Scientific Title | Effect of the mouth care of newborn baby during N-CPAP |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2018/02/04 01:47:13 |
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Basic information
Public title
Effect of the mouth care of newborn baby during N-CPAP
Acronym
Effect of the mouth care of newborn baby during N-CPAP
Scientific Title
Effect of the mouth care of newborn baby during N-CPAP
Scientific Title:Acronym
Effect of the mouth care of newborn baby during N-CPAP
Region
| Japan |
Condition
Condition
Neonatal respiratory disorder
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To decrease the rate of non-intraoral indigenous bacterium detection and to prevent the infection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decreasing the rate of non-intraoral indigenous bacterium by using the intraoral culture.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform the mouth care during nasal-continuous positive airway pressure three times a day at4:00,13:00 and 22:00.
Interventions/Control_2
Didn't performed the periodic mouth care during nasal-continuous positive airway pressure.
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
| Not applicable |
Age-upper limit
| 4 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
The newborn baby performed nasal-continuous positive airway pressure more than two days.
Key exclusion criteria
The newborn baby detected the non-intraoral indigenous bacterium before nasal-continuous positive airway pressure by the intraoral culture.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuuki Nakaya |
Organization
Yamaguchi University Hospital
Division name
Nursing department The first ward fourth floor east(NICU)
Zip code
Address
1-1-1 Minami-kogushi,Ube,Yamaguchi
TEL
0836-22-2730
yuuki-n@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuuki Nakaya |
Organization
Yamaguchi University Hospital
Division name
Nursing department The first ward fourth floor east(NICU)
Zip code
Address
1-1-1 Minami-kogushi,Ube,Yamaguchi
TEL
0836-22-2730
Homepage URL
yuuki-n@yamaguchi-u.ac.jp
Sponsor or person
Institute
The first ward fourth floor east(NICU)
Institute
Department
Personal name
Funding Source
Organization
Nursing department
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
| 2016 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2018 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024031
