UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020531
Receipt number R000021550
Scientific Title A cohort study for asthma predictive marker in Japanese infants with their first wheeze
Date of disclosure of the study information 2016/01/12
Last modified on 2019/07/16 20:06:02

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Basic information

Public title

A cohort study for asthma predictive marker in Japanese infants with their first wheeze

Acronym

Predictive markers at the first time of wheezes for asthma developmemt in Japanese infants

Scientific Title

A cohort study for asthma predictive marker in Japanese infants with their first wheeze

Scientific Title:Acronym

Predictive markers at the first time of wheezes for asthma developmemt in Japanese infants

Region

Japan


Condition

Condition

acute bronchitis

Classification by specialty

Clinical immunology Pediatrics Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To observe biomarkers prospectivey in patients' nasal discharge at their first time of wheeze.To validate our prior research and to seek a cut off level for MIP1-alfa.

Basic objectives2

Others

Basic objectives -Others

To investigate sensitization for allergens in children with recurrent wheeze.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Clinical usefulness and cut off level of MIP1-alfa in first wheeze infants.

Key secondary outcomes

Sensitization for allergens and food allergy in infants with recurrent wheeze and development of asthma.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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 months-old <=

Age-upper limit

24 months-old >

Gender

Male and Female

Key inclusion criteria

Infants who have the first wheezing episodes with viral lower respiratory infection.

Key exclusion criteria

1 Patients who have been diagnosed as asthma or habe been had wheezing episodes before enrollment.

2. Preterm infants

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kazuko
Middle name
Last name Sugai

Organization

Sugai children's clinic

Division name

Department of Pediatrics

Zip code

7300044

Address

2-1Takara-machi, Naka-ku,Hiroshima city,Hiroshima

TEL

+81822073888

Email

kazgoto@be.mbn.or.jp


Public contact

Name of contact person

1st name Kazuko
Middle name
Last name Kazuko Sugai

Organization

Sugai Children's clinic

Division name

Department of Pediatrics

Zip code

7300044

Address

2-1 Takaramachi, Naka-ku,Hiroshima-city

TEL

+81822073888

Homepage URL


Email

kazgoto@be.mbn.or.jp


Sponsor or person

Institute

Sugai children's clinic

Institute

Department

Personal name



Funding Source

Organization

Sugai children's clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nihon University
Dokkyo Medical University
National Institute of Infectious Diseases

Name of secondary funder(s)



IRB Contact (For public release)

Organization

National hospital organization fukuyama medical center

Address

4-14-17, Okinogami-cho, Fukuyama, Hiroshima,720-8520 Japan

Tel

+81849220001

Email

rinnshou@fukuyama-hosp.go.jp


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

国立病院機構福山医療センター(広島県)
日本大学(東京都)
獨協医科大学(栃木県)


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 12 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

Terminated

Date of protocol fixation

2015 Year 07 Month 22 Day

Date of IRB

2015 Year 07 Month 22 Day

Anticipated trial start date

2015 Year 07 Month 22 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information

Analyze biomarkers of nasopharyngeal discharses from infants who have their first wheezing episodes.


Management information

Registered date

2016 Year 01 Month 12 Day

Last modified on

2019 Year 07 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021550


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name