UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012445
Receipt number 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 16:41:09

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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

Japan


Condition

Condition

Childhood injury

Classification by specialty

Pediatrics Emergency medicine

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

Behavior,custom Other

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


 Not applicable

Age-upper limit


 Not applicable

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

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

03-3416-0181

Email

fujiwara-tk@ncchd.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoko Fukuhara

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


Email

fukuhara-y@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


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



Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 29 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

Enrolling by invitation

Date of protocol fixation

2013 Year 10 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 19 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

2013 Year 11 Month 29 Day

Last modified on

2013 Year 11 Month 29 Day



Link to view the page

Value
https://center6.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