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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | Death by asphyxiation | |||
Classification by specialty |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | Cases in which refusal to participate in the study was requested
Death by asphyxiation due to aspiration |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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
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Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |