UMIN-CTR Clinical Trial

Public title

A study to evaluate usefulness of biphasic extrathoracic cuirass ventilation (BCV) for acute respiratory failure in infants: A multicenter randomized controlled test with standard treatment as the control.

Acronym

RCT of BCV for acute respiratory failure in infants

Scientific Title

A study to evaluate usefulness of biphasic extrathoracic cuirass ventilation (BCV) for acute respiratory failure in infants: A multicenter randomized controlled test with standard treatment as the control.

Scientific Title:Acronym

RCT of BCV for acute respiratory failure in infants

Region

Japan

Condition

respiratory tract infection

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We wanted to investigate the effect of BCV for respiratory distress in infants by comparing with standard treatment as a control.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The rate of infants who required additional treatments, including mechanical ventilation (CMV, NPPV and BCV) due to respiratory distress induring 24 hours after treatent.

Key secondary outcomes

Blood gas analysis at 1 hour after treatment.
VAS(Visual analogue scale)1 hour after treatment.
mPIS at 1,2 and 3 hours after treatment.
mPIS at 24 hours after treatment.
mPIS when BCV could be discontinued because of an improvement of symptoms.
mPIS when the management by positive pressure ventilation was started because of worsening of symptoms.
The frequency of additional treatments due to worsening of symptoms during the periods from the entrance to the end of the trial.
Validity of of the timing to discontinue BCV.
The number of infants BCV was restarted because of wosening of symptoms.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Biphasic cuirass ventiration

Interventions/Control_2

Control treatment

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

0

years-old

<=

Age-upper limit

2

years-old

>

Gender

Male and Female

Key inclusion criteria

The criteria of subjects in the present study were as following;
Less than 2 years old
sPO2 level was between the value of 90% or more and less than 95%.
Those who were diagnosed as respiratory diseases including bronchitis, pneumonia, bronchiolitis and so on.
A written consent was obtained from the guardian.

Key exclusion criteria

Children requiring intratracheal intubation or mechanical ventilation (CMV: Conventional NPPV: Non-invasive Positive Pressure Ventilation) on admission.
Children whose symptoms have been diagnosed as acute asthma attack.
Children with circulatory failure.
Children with primary disease (cyanotic heart disease, chronic lung disease, upper airway disease, thoracic deformity, cerebral palsy, congenital metabolic disorder).
Severely multiple handicapped children.
Children who were estimated not to be suitable for the study subjects by the attending physician.

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Yutaka Ueda

Organization

Saitama Medical University Hospital

Division name

Pediatrics

Zip code

Address

Saitama prf. iruma-gun moroyama-machi morohongo38

TEL

049-276-1218

Email

y_ueda@saitama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Yutaka Ueda

Organization

Saitama Medical University Hospital

Division name

Pediatrics

Zip code

Address

Saitama prf. iruma-gun moroyama-machi morohongo38

TEL

049-276-1218

Homepage URL

Email

y_ueda@saitama-med.ac.jp

Institute

Saitama Medical University Hospital department of Pediatrics

Institute

Department

Personal name

Organization

Kawano masanoriMedical Public Internet Incorprated Fundation for Promotion of Pediatrics.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

埼玉医科大学病院（埼玉県）

Date of disclosure of the study information

2014

Year

12

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

12

Month

09

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

06

Day

Last follow-up date

2017

Year

08

Month

31

Day

Date of closure to data entry

2017

Year

08

Month

31

Day

Date trial data considered complete

2017

Year

09

Month

19

Day

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

09

Day

Last modified on

2017

Year

10

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017749