UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025243
Receipt number R000029038
Scientific Title Establishment of the algorithm for reccurent infant wheezing under 2 years of age
Date of disclosure of the study information 2017/01/04
Last modified on 2018/12/17 08:47:01

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Basic information

Public title

Establishment of the algorithm for reccurent infant wheezing under 2 years of age

Acronym

The algorithm for infant wheeze

Scientific Title

Establishment of the algorithm for reccurent infant wheezing under 2 years of age

Scientific Title:Acronym

The algorithm for infant wheeze

Region

Japan


Condition

Condition

Infant wheeze

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish the algorithms to distinguish between multiple diseases that cause infant wheezing with safely and efficiently

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Percentage of identified underlying diseases that cuase infant wheeze

Key secondary outcomes

How infant wheeze improves by intervening in the idenfitied underlying disease at 1-year follow up.


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

8

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Suspected infatn asthma.

Administer a systemic steroid therapy.
Prednisolone 1.5mg/kg/day, 3x iv.

Interventions/Control_2

Lower respiratory infection.

Administer physical therapy and/or antibiotic treatment.
CTX 100mg/kg/day, 3x iv.

Interventions/Control_3

Suspected airway ciliary movement abnormality.

Administer low-dose macrolide therapy.
Clarithromycin 5mg/kg/day, 1x po.

Interventions/Control_4

Suspected gastroesophageal reflux disease.

Administer H2-blocker therapy.
Famotidine 1mg/kg/day, 2x po.

Interventions/Control_5

Suspected of congenital immunodeficiency.

Administer immunoglobulin replacement therapy and/or low-dose macrolide therapy as necessary.
Immunoglobulin 300mg/kg for 1st time, 200mg/kg for the second and subsequent times.

Interventions/Control_6

Congenital heart disease.

Operate surgical treatment and/or administer medication for heart failure as necessary.

Interventions/Control_7

Bronchial morphology abnormality.

Operate surgical treatment and/or administer medication as necessary.

Interventions/Control_8

Mixed diseases with above underlying diseases and infant asthma.

In addition to the treatment described above, administer a systemic steroid therapy.

Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

2 months-old <=

Age-upper limit

24 months-old >=

Gender

Male and Female

Key inclusion criteria

Infant admitted to our hospital with lower respiratory tract inflammation (pneumonia, bronchitis, bronchiolitis)

Key exclusion criteria

Infants who have already been diagnosed with respiratory disease such as cerebral palsy, diaphragmatic hernia, chronic lung disease

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mari Saito

Organization

Haga Red Cross Hospital

Division name

Pediatrics

Zip code


Address

2461 Daimachi, Mouka, Tochigi, Japan

TEL

0285-52-2195

Email

mari.saito@haga.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mari Saito

Organization

Haga Red Cross Hospital

Division name

Pediatrics

Zip code


Address

2461 Daimachi, Mouka, Tochigi, Japan

TEL

0285-52-2195

Homepage URL


Email

mari.saito@haga.jrc.or.jp


Sponsor or person

Institute

Haga Red Cross Hospital

Institute

Department

Personal name



Funding Source

Organization

Not applicable

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


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



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 04 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

Completed

Date of protocol fixation

2017 Year 01 Month 04 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2018 Year 12 Month 17 Day

Date of closure to data entry

2018 Year 12 Month 17 Day

Date trial data considered complete

2018 Year 12 Month 17 Day

Date analysis concluded

2018 Year 12 Month 17 Day


Other

Other related information



Management information

Registered date

2016 Year 12 Month 13 Day

Last modified on

2018 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029038


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name