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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004928
Receipt No. 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

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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
Email

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
Email ootsukataketo@hotmail.com

Sponsor
Institute Department of Pediatrics, Sado General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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