UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042990 |
|---|---|
| Receipt number | R000049081 |
| Scientific Title | Screening and Follow-up Teaching Method of Infantile Asthma using Lung Sound Analysis |
| Date of disclosure of the study information | 2021/01/18 |
| Last modified on | 2024/01/16 10:20:00 |
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Basic information
Public title
Screening and Follow-up Teaching Method of Infantile Asthma using Lung Sound Analysis
Acronym
Screening Method of Infantile Asthma using Lung Sound Analysis
Scientific Title
Screening and Follow-up Teaching Method of Infantile Asthma using Lung Sound Analysis
Scientific Title:Acronym
Screening Method of Infantile Asthma using Lung Sound Analysis
Region
| Japan |
Condition
Condition
healthy infants
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to create a meaningful early intervention and follow-up guidance method using the criteria of the high-risk group of infantile asthma with the results of lung sound analysis .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In the high-risk group of infantile asthma, the onset and aggravation of asthma can be suppressed by providing early intervantion guideline before the onset of asthma.
Key secondary outcomes
In the high-risk group of infantile asthma, wheezing and allergen sensitization can be suppressed by providing early intervantion guideline before the onset of asthma.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Guidance and education to parents such as environmental adjustment
Interventions/Control_2
High-risk group and non-high-risk group of infantile asthma
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
| 4 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
age
Key exclusion criteria
Patients with asthma, respiratory diseases, heart diseases and other serious diseases
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Mochizuki |
Organization
Tokai University School of Medicine
Division name
Pediatrics
Zip code
259-1193
Address
143 Shimokasuya, Isehara
TEL
+81463931121
mochihi@tokai-u.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Mochizuki |
Organization
Tokai University School of Medicine
Division name
Pediatrics
Zip code
2591193
Address
143 Shimokasuya, Isehara
TEL
+81463931121
Homepage URL
mochihi@tokai-u.jp
Sponsor or person
Institute
Tokai University School of Medicine,
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
the Environmental Restoration and Conservation Agency of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institution review board for clinical research, Tokai University
Address
143 Shimokasuya, Isehara
Tel
+81463931121
mochihi@tokai-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
https://www.erca.go.jp/yobou/zensoku/investrary/12.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.erca.go.jp/yobou/zensoku/investrary/12.html
Number of participants that the trial has enrolled
392
Results
The new coronavirus pandemic was seen around the world, and it was difficult to carry out our main research. However, some studies related with questionnaire have shown that (1) infants with atopy have differences in respiratory physiology from normal infants, (2) airway changes occur in infants after respiratory tract infection, (3) airway reversibility can evaluate by lung sound analysis, and (4) progress was made in full-automating lung sound analysis.
Results date posted
| 2024 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Infants who participated in infant health checkups held at pediatric facilities: Tokai University, Dokkyo Medical University and National Yokohama Center.
Participant flow
This study started in the spring of 2019, and preparations were completed in one year. However, the new coronavirus pandemic occurred at the stage of starting the main study (spring, 2020), and the infant health checkup was postponed. Major negative factors arose, including postponing infant health checkups and an inability to conduct inhalation tests. As a result, the study related with the questionnaire was completed. However, due to the small number of participants in the study of the evaluation method for differentiating asthma-high-risk children (300 in the plan, 9 in reality), it was not possible to analyze the results.
Adverse events
No
Outcome measures
Creation of criteria for high-risk groups for developing asthma and evaluation of early intervention methods and follow-up guidance methods based on these criteria
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049081
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