UMIN-CTR Clinical Trial

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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