UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015558 |
|---|---|
| Receipt number | R000018076 |
| Scientific Title | Cluster randomized trial to evaluate the effectiveness of educational material to prevent shaken baby syndrome in obstetric clinic |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2014/10/29 09:07:37 |
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Basic information
Public title
Cluster randomized trial to evaluate the effectiveness of educational material to prevent shaken baby syndrome in obstetric clinic
Acronym
Study to evaluate the effectiveness of educational material to prevent shaken baby syndrome in obstetric clinic
Scientific Title
Cluster randomized trial to evaluate the effectiveness of educational material to prevent shaken baby syndrome in obstetric clinic
Scientific Title:Acronym
Study to evaluate the effectiveness of educational material to prevent shaken baby syndrome in obstetric clinic
Region
| Japan |
Condition
Condition
Shaken baby syndrome
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of educational material focusing on feature of infant crying to prevent abusive behaviors such as shaking and smothering at obstetric clinic.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Abusive behaviors (shaking and smothering)
Key secondary outcomes
1. Knowledge on infant crying
2. Knowledge on shaking
3. Behavior when infant crying
4. Behavior to sharing information on infant crying with other family memnber
5. Walk away behavior when unsoothable crying
6. Postpartum depression (EPDS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Watch DVD "Baby doesn't stop crying" created by Ministry of Health, Labour, and Welfare, during administered at obstetric clinic
Interventions/Control_2
Watch DVD "Baby doesn't stop crying" created by Ministry of Health, Labour, and Welfare, at 1st month health checkup.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
All mothers who deliver babies at obstetric clinics in Osawa which joined this study
Key exclusion criteria
Still birth and deliver <22 weeks gestational age
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeo Fujiwara |
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
03-3417-2663
fujiwara-tk@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Sekiguchi |
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
03-3417-2663
Homepage URL
sekiguchi-m@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
大阪府立母子保健総合医療センター（大阪府）等
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
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
| 2014 | Year | 10 | Month | 29 | Day |
Last modified on
| 2014 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018076
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
