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
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
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
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
