UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022158 |
|---|---|
| Receipt number | R000025534 |
| Scientific Title | The effect of sustained inflation in very low birth weight infants ventilated with high frequency oscillation: a randomized crossover trial. |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2016/04/30 23:22:18 |
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Basic information
Public title
The effect of sustained inflation in very low birth weight infants ventilated with high frequency oscillation: a randomized crossover trial.
Acronym
The effect of sustained inflation in preterm infants with high frequency oscillation: a randomized crossover trial.
Scientific Title
The effect of sustained inflation in very low birth weight infants ventilated with high frequency oscillation: a randomized crossover trial.
Scientific Title:Acronym
The effect of sustained inflation in preterm infants with high frequency oscillation: a randomized crossover trial.
Region
| Japan |
Condition
Condition
Very low birth weight infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of sustained inflation combined with high frequency oscillation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of desaturation(SpO2<80%)
Key secondary outcomes
Heart rate
Transcutaneous CO2
Cerebral and peripheral blood flow
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
With Sustained Inflation(SI)and without SI.
6 hours later,we change with SI(or without SI), 30minutes of wash out time, we observe 6 hours.
Interventions/Control_2
With Sustained Inflation(SI)and without SI.
6 hours later,we change with SI(or without SI), 30minutes of wash out time, we observe 6 hours.
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
| 1 | weeks-old | <= |
Age-upper limit
| 48 | weeks-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Birth weight <1500g
(2)ventilated with HFO(Babylog VN500)
(3)age>1 week after birth
(4)No change of ventilator settings (MAP,Amplitude,VT,frequency)
(5)agreement of their parents to participate in this study
Key exclusion criteria
(1)unstable lung condition(i.e pneumonia, pneumothorax)
(2)a case that attending physician consider inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Tamura |
Organization
Takatsuki General Hospital
Division name
Department of Pediatrics and Neonatology
Zip code
Address
1-3-13 Kosobe, Takatsuki, Osaka 569-1192, Japan
TEL
072-681-3801
mako0803qoo@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Tamura |
Organization
Takatsuki General Hospital
Division name
Department of Pediatrics and Neonatology
Zip code
Address
1-3-13 Kosobe, Takatsuki, Osaka 569-1192, Japan
TEL
072-681-3801
Homepage URL
mako0803qoo@gmail.com
Sponsor or person
Institute
Takatsuki General Hospital
Institute
Department
Personal name
Funding Source
Organization
Takatsuki General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
高槻病院（大阪府） Takatsuki General Hospital（Osaka, Japan）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 30 | Day |
Last modified on
| 2016 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025534
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
