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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name