UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046607 |
|---|---|
| Receipt number | 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 | 2023/07/17 12:11:42 |
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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
| Obstetrics 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
Target sample size
30
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
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
ytateoka@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University Of Medical Science
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
Results
Of the 28 infants who died of suffocation during sleep, in 16 cases this was due to co-sleeping or breastfeeding in the side-lying position. These infants had shown normal development. The results showed that suffocation death more frequently occurs with infants who showed common-cold symptoms and/or had multiparous mothers. In addition, suffocation death due to co-sleeping was shown to occur more often at younger ages within the 0 to 1 year range, in winter, and late at night.
Results date posted
| 2023 | Year | 01 | Month | 19 | Day |
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
Main results already published
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
| 2023 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053167
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/01/19 | 【資料１】研究計画書R2021-136.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
