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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015558
Receipt No. 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

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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
Last 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
Email fujiwara-tk@ncchd.go.jp

Public contact
1st 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
Email sekiguchi-m@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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018076

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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