UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052165 |
|---|---|
| Receipt number | R000059491 |
| Scientific Title | Impact of birth weight, environment and respiratory diseases in childhood on obstructive ventilatory impairment in adulthood |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/09/10 11:11:49 |
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Basic information
Public title
Impact of birth weight, environment and respiratory diseases in childhood on pulmonary function in adulthood
Acronym
Diseases in childhood and pulmonary function in adulthood
Scientific Title
Impact of birth weight, environment and respiratory diseases in childhood on obstructive ventilatory impairment in adulthood
Scientific Title:Acronym
Early life events and pulmonary function in adulthood
Region
| Japan |
Condition
Condition
Obstructive pulmonary diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of birth weight, environment, and respiratory diseases in childhood on obstructive pulmonary impairment in adulthood
Basic objectives2
Others
Basic objectives -Others
To characterize the clinical feature of patients with obstructive disorder caused by the events related to low birth weight
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of birth weight with pulmonary function parameters (FEV1/FVC, %FEV1, %VC)
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.FEV1/FVC<0.7 or %FEV1<80
2.FEV1/FVC>0.7 and %FEV1>80
Key exclusion criteria
Subjects who cannot participate in the study
Patients with interstitial lung diseases causing reduction of %FEV1(obstructive pulmonary disease)
Subjects with abnormal findings in chest x-ray causing changes in pulmonary function (normal spirometry)
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Medical University Hospital
Division name
Department of Respiratory Medicine
Zip code
3500495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
81-49-276-1319
hnakamur@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Medical University Hospital
Division name
Department of Respiratory Medicine
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
81-49-276-1319
Homepage URL
hnakamur@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Hidetoshi Nakamura
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Japanese Respiratory Society
Name of secondary funder(s)
Saitama Medical University
IRB Contact (For public release)
Organization
Saitama Medical University Central Ethics Review Committee
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
81492761662
chuoirb@saitama-med.ac.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
| 2024 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Joint research institutes(Nara Medical University, Shiga Medical University, Tohoku University, Aichi Medical University, Yamaguchi University, Keio University, Saitama Medical Center, Saitama Municipal Hospital, Hino Municipal Hospital, Tokyo Saiseikai Central Hospital, JCHO Saitama Medical Center, Kyoto University)
Study groups(Obstructive diseases/Very low birth weight,Obstructive diseases/Low birth weight, Obstructive diseases/Normal birth weight, Healthy subjects/Normal birth weight)
Primary research(birth weight, environment in childhood, diseases in cheldhood, environment in adulthood, diseases in adulthood, pulmonary functions, comorbidities)
Secondary research(respiratory management during birth, respiratory symptoms, mental status, physical activity, QOL)
Management information
Registered date
| 2023 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059491
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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