UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014966 |
|---|---|
| Receipt number | R000017421 |
| Scientific Title | A study of sensitization for allergen and mechanism on development of allergic disease in early childhood |
| Date of disclosure of the study information | 2014/08/27 |
| Last modified on | 2014/08/27 13:41:19 |
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Basic information
Public title
A study of sensitization for allergen and mechanism on development of allergic disease in early childhood
Acronym
A study of sensitization for allergen and mechanism on development of allergic disease in early childhood
Scientific Title
A study of sensitization for allergen and mechanism on development of allergic disease in early childhood
Scientific Title:Acronym
A study of sensitization for allergen and mechanism on development of allergic disease in early childhood
Region
| Japan |
Condition
Condition
high risk infants of allargic disease and their mothers
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the relationship between sensitization for allergen in early childhood and development of allergic disease using blood examination in high risk infants with allergic disease and consider whether we can control sensitization for allergen and the allergic manifestations by effective early intervention.
Basic objectives2
Others
Basic objectives -Others
The timing of sensitization for allergen and the development of allergic disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of allergic sensitization and symptoms at birth,one month old,six months old,12 months old,18 months old and 24 months old
Key secondary outcomes
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
| 0 | months-old | <= |
Age-upper limit
| 24 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
the infants whose relatives within the third degree of relationship have allergic diseases
Key exclusion criteria
low birth weight infants
premature infants
infants that have severe complication
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Tsuchimoto |
Organization
National Hospital Organization Fukuyama Medical Center
Division name
Department of pediatrics
Zip code
Address
4-14-17 Okinogami-cho,Fukuyama,Hiroshima,Japan
TEL
084-922-0001
tsuchimoto_keiji@fukuyama-hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Ikeda |
Organization
National Hospital Organization Fukuyama Medical Center
Division name
Department of clinical research
Zip code
Address
4-14-17 Okinogami-cho,Fukuyama,Hiroshima,Japan
TEL
084-922-0001
Homepage URL
ikeda_masanori@fukuyama-hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Fukuyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Fukuyama Medical Center
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 08 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Development of allergic sensitization and symptoms at birth,one month old,six months old,12 months old,18 months old and 24 months old
Management information
Registered date
| 2014 | Year | 08 | Month | 27 | Day |
Last modified on
| 2014 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017421
