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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046607
Receipt No. R000053167
Scientific Title Study on death by suffocation of breastfeeding while co-sleeping
Date of disclosure of the study information 2022/01/12
Last modified on 2022/01/12

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Basic information
Public title Study on death by suffocation of breastfeeding while co-sleeping
Acronym Study on death by suffocation of breastfeeding while co-sleeping
Scientific Title Study on death by suffocation of breastfeeding while co-sleeping
Scientific Title:Acronym Study on death by suffocation of breastfeeding while co-sleeping
Region
Japan

Condition
Condition Death by asphyxiation
Classification by specialty
Obsterics and gynecology Pediatrics Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the actual situation and problems related to suffocation deaths of infants caused by co-sleeping and breastfeeding
Basic objectives2 Others
Basic objectives -Others To examine problems related to infant asphyxia from autopsy cases of asphyxia deaths that occurred in the past, using forensic knowledge.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Breastfeeding posture and environment during co-sleeping and breastfeeding
Key secondary outcomes Differences in various factors between co-sleeping and breastfeeding asphyxia and other bedtime asphyxia deaths

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
1 years-old <=
Age-upper limit
1 years-old >
Gender Male and Female
Key inclusion criteria 0 weeks to under 1 year of age
A case of suffocation during sleep
Cases with forensic autopsies between January 1, 2010 and July 31, 2021.
Key exclusion criteria Cases in which refusal to participate in the study was requested
Death by asphyxiation due to aspiration
Target sample size 20

Research contact person
Name of lead principal investigator
1st name YUMIKO
Middle name
Last name TATEOKA
Organization Shiga University Of Medical Science
Division name Faculty of Nursing
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu,Shiga
TEL 077-548-2433
Email ytateoka@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name YUMIKO
Middle name
Last name TATEOKA
Organization Shiga University Of Medical Science
Division name Faculty of Nursing
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu,Shiga
TEL 077-548-2433
Homepage URL
Email ytateoka@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University Of Medical Science
Institute
Department

Funding Source
Organization Shiga University Of Medical Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shiga University Of Medical Science
Address Seta Tsukinowa-cho, Otsu,Shiga
Tel 0775482433
Email ytateoka@belle.shiga-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 滋賀医科大学

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 12 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
2021 Year 11 Month 10 Day
Date of IRB
2021 Year 11 Month 18 Day
Anticipated trial start date
2022 Year 01 Month 24 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Height and weight at time of death, upbringing, underlying/previous diseases, family structure, circumstances of accident, sleeping environment, factors that may cause suffocation

Management information
Registered date
2022 Year 01 Month 12 Day
Last modified on
2022 Year 01 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053167

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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