UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022158
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mako0803qoo@gmail.com

Sponsor
Institute Takatsuki General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025534

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.