UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004928 |
|---|---|
| Receipt number | R000005866 |
| Scientific Title | Epidemiological Risk Factors for Bacterial Colonization in an Area Under Controlled Antimicrobial Use; Birth Cohort Study in Sado Island, Japan (SADO-study) |
| Date of disclosure of the study information | 2011/01/25 |
| Last modified on | 2013/07/23 01:04:33 |
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Basic information
Public title
Epidemiological Risk Factors for Bacterial Colonization in an Area Under Controlled Antimicrobial Use; Birth Cohort Study in Sado Island, Japan (SADO-study)
Acronym
Epidemiological Risk Factors for Bacterial Colonization in an Area Under Controlled Antimicrobial Use; Birth Cohort Study in Sado Island, Japan (SADO-study)
Scientific Title
Epidemiological Risk Factors for Bacterial Colonization in an Area Under Controlled Antimicrobial Use; Birth Cohort Study in Sado Island, Japan (SADO-study)
Scientific Title:Acronym
Epidemiological Risk Factors for Bacterial Colonization in an Area Under Controlled Antimicrobial Use; Birth Cohort Study in Sado Island, Japan (SADO-study)
Region
| Japan |
Condition
Condition
Bacterial meningitis, Sepsis, Pneumonia, Acute otitis media
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the risk factors for bacterial colonization and its resistance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Odds ratio for bacterial colonization and its resistance by variable.
Key secondary outcomes
Colonization rate and resistance rate at 4 month, 7 month, 10 month, 18 month, 36 month of age.
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 | years-old | <= |
Age-upper limit
| 3 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Newborns were born in Sado Island
2) Their guardians could understand the protocol of this study
3) Written informed consent of the their guardians
Key exclusion criteria
1) newborns had plan to move to other areas within 3 years
2) newborns had major congenital malformation
3) For other reasons, newborns determined to be inappropriate for study entry by investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taketo Otsuka |
Organization
Sado General Hospital
Division name
Department of Pediatrics
Zip code
Address
113-1 Chigusa , Sado, Niigata, Japan
TEL
0259-63-3121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taketo Otsuka |
Organization
Sado General Hospital
Division name
Department of Pediatrics
Zip code
Address
113-1 Chigusa , Sado, Niigata, Japan
TEL
0259-63-3121
Homepage URL
ootsukataketo@hotmail.com
Sponsor or person
Institute
Department of Pediatrics, Sado General Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Luke's Life Science Institute
Mother and Child Health Foundation
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Wakayama Medical University
Name of secondary funder(s)
Wakayama-Okayama Otolaryngology Pharma
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
佐渡総合病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 01 | Day |
Other
Other related information
A total of 349 newborns were enrolled.
Management information
Registered date
| 2011 | Year | 01 | Month | 22 | Day |
Last modified on
| 2013 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005866
