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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000012445 |
Receipt No. | R000014420 |
Scientific Title | Study to prevent childhood injury by paternal child care: A randomized controlled trial |
Date of disclosure of the study information | 2013/11/29 |
Last modified on | 2013/11/29 |
Basic information | ||
Public title | Study to prevent childhood injury by paternal child care: A randomized controlled trial | |
Acronym | Study to prevent childhood injury by paternal child care: A randomized controlled trial | |
Scientific Title | Study to prevent childhood injury by paternal child care: A randomized controlled trial | |
Scientific Title:Acronym | Study to prevent childhood injury by paternal child care: A randomized controlled trial | |
Region |
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Condition | |||
Condition | Childhood injury | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To show the effectiveness to prevent childhood injury facilitating paternal child care using educational material |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Prevalence of childhood injury |
Key secondary outcomes | Paternal child care, Maternal stress due to child care, Parental attachment with child |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Central registration |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Prevention | ||
Type of intervention |
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Interventions/Control_1 | Provided and watch DVD intended to facilitate parental child care when the infant is aged 2-4 weeks | ||
Interventions/Control_2 | Provided and watch DVD regarding infant crying and shaken baby syndrome when the infant is aged 2-4 weeks | ||
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 | Parents and infants born at National Research Institute for Child Health and Development and Iino hospital | |||
Key exclusion criteria | Unable to watch DVD, having difficulty with Japanese language used in questionnaire, physician considered not suitable (e.g. mental disease), father is not living with due to work, single parent, multiple birth, infants who have to stay in NICU | |||
Target sample size | 1500 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Research Institute for Child Health and Development | ||||||
Division name | Department of Social Medicine | ||||||
Zip code | |||||||
Address | 2-10-1, Okura, Setagaya-ku, Tokyo | ||||||
TEL | 03-3416-0181 | ||||||
fujiwara-tk@ncchd.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Research Institute for Child Health and Development | ||||||
Division name | Department of Social Medicine | ||||||
Zip code | |||||||
Address | 2-10-1, Okura, Setagaya-ku, Tokyo | ||||||
TEL | 03-3416-0181 | ||||||
Homepage URL | |||||||
fukuhara-y@ncchd.go.jp |
Sponsor | |
Institute | National Center for Child Health and Development |
Institute | |
Department |
Funding Source | |
Organization | National Center for Child Health and Development |
Organization | |
Division | |
Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014420 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |