UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044876 |
|---|---|
| Receipt number | R000051255 |
| Scientific Title | Sleep health in infants and parents: a prospective cohort study |
| Date of disclosure of the study information | 2021/07/21 |
| Last modified on | 2022/07/19 08:56:54 |
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Basic information
Public title
Sleep health in infants and parents: a prospective cohort study
Acronym
SHIPs cohort
Scientific Title
Sleep health in infants and parents: a prospective cohort study
Scientific Title:Acronym
SHIPs cohort
Region
| Japan |
Condition
Condition
Infants and children without congenital abnormalies
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of infant sleep problems (short sleep duration, wake time after sleep onset) on behavioral problems and mental/physical health, and to examine the determinants of these problems
Basic objectives2
Others
Basic objectives -Others
Developmental changes in sleep duration; a prospective cohort study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Strength and Difficulties Questionnaire: SDQ
Key secondary outcomes
The PedsQL Generic Core Scales Parent Proxy-Report Ages 0-12month, 13-24month, 2-4yrs, 5-7yrs
Obesity = (actual weight - standard weight) / standard weight x 100 (%)
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
| 4 | months-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Infants born on or after April 2, 2016
2. Those eligible for the 4-month, 10-month, 1.5-year, 3-year, and 5-year infant health checkups and their parents who have obtained written informed consent
Key exclusion criteria
1. Participants who cannot obtain written informed consent for this study from their parents or individuals with parental authority
2. Infants with congenital abnormalies including a congenital disease and metabolic disorders
3. Infants born less than 37 weeks of gestation
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Norihisa |
| Middle name | |
| Last name | Tamura |
Organization
Graduate School of Humanities and Social Sciences
Division name
Department of Psychology
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
TEL
082-424-6803
tamura65@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihisa |
| Middle name | |
| Last name | Tamura |
Organization
Graduate School of Humanities and Social Sciences
Division name
Department of Psychology
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
TEL
082-424-6803
Homepage URL
tamura65@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Challenging Exploratory Research
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
Hiroshima University Graduate School of Humanities and Social Sciences, Ethics Committee
Address
1-1-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
Tel
082-424-7190
ed-ken-zai@office.hiroshima-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 21 | 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
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study design is a prospective cohort study.
Management information
Registered date
| 2021 | Year | 07 | Month | 15 | Day |
Last modified on
| 2022 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051255
