UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019696
Receipt number R000022307
Scientific Title Activity and sleep assessment of full-term infant
Date of disclosure of the study information 2016/02/15
Last modified on 2016/02/15 09:48:16

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Basic information

Public title

Activity and sleep assessment of full-term infant

Acronym

Activity and sleep assessment of full-term infant
(ASAF)

Scientific Title

Activity and sleep assessment of full-term infant

Scientific Title:Acronym

Activity and sleep assessment of full-term infant
(ASAF)

Region

Japan


Condition

Condition

Full-term infants

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will examine the efficacy of actigraphs in assessment of activity and sleep in infants of 18 months of age.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Nighttime sleep durations of infants of 18 months of age

Key secondary outcomes

Nap duration
Nap end time
Sleep onset time
WASO
Daytime activity


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

1 years-old <=

Age-upper limit

6 years-old >=

Gender

Male and Female

Key inclusion criteria

Born between 37 and 42 weeks' gestational age.

Key exclusion criteria

(1)Severe illness or congenital abnormality (2) Use of infant medication with sedative effects.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Isao Kusakawa

Organization

St. Luke's international Hospital

Division name

Pediatrics

Zip code


Address

Akashi-cho 9-1, Chuou-ku, Tokyo

TEL

03-3541-5151

Email

isaokusa@luke.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Machiko Nakagawa

Organization

St. Luke's international Hospital

Division name

Pediatrics

Zip code


Address

Akashi-cho 9-1, Chuou-ku, Tokyo

TEL

03-3541-5151

Homepage URL


Email

machina@luke.ac.jp


Sponsor or person

Institute

St. Luke's international Hospital

Institute

Department

Personal name



Funding Source

Organization

St. Luke's Life Science Institute

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



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

2016 Year 02 Month 15 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

2013 Year 04 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 06 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

Observation


Management information

Registered date

2015 Year 11 Month 09 Day

Last modified on

2016 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022307


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name