UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of sustained inflation in very low birth weight infants ventilated with high frequency oscillation: a randomized crossover trial.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Makoto Tamura
Organization	Takatsuki General Hospital
Division name	Department of Pediatrics and Neonatology
Address	1-3-13 Kosobe, Takatsuki, Osaka 569-1192, Japan
TEL	072-681-3801
Email	mako0803qoo@gmail.com

Public contact
Name of contact person	Makoto Tamura
Organization	Takatsuki General Hospital
Division name	Department of Pediatrics and Neonatology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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