UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014859 |
|---|---|
| Receipt number | R000016834 |
| Scientific Title | The effect of night-time lighting on preterm infants |
| Date of disclosure of the study information | 2014/08/14 |
| Last modified on | 2015/03/02 10:38:00 |
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Basic information
Public title
The effect of night-time lighting on preterm infants
Acronym
Lighting At Night on Preterms (LANP)
Scientific Title
The effect of night-time lighting on preterm infants
Scientific Title:Acronym
Lighting At Night on Preterms (LANP)
Region
| Japan |
Condition
Condition
Preterm infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To protect infants from the negative effects of nighttime light on their development in the NICU, we plan to develop an LED light with a red light which is invisible to infants. We will examine whether use of the LED light for night-time medical care, feeding and diaper changes of preterm infants in an LD cycle can induce better sleep development and body growth than normal white light exposure at night.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The ratio between day and night activity
Key secondary outcomes
(1) The frequency of night-time crying
(2) The gain of body weight
(3) The secretion of salivary cortisol at night
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the control group, white LED light is used for nursing care procedures such as nursing, feeding and changing diapers.
Interventions/Control_2
In the experimental group, red LED light is used for the same nursing care procedures performed in the control group.
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
| 1 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Infants were eligible for enrollment if they had no current significant medical problems and were born at < 34 week's postmenstrual age
Key exclusion criteria
(1) Infants with significant eye disease (retinopathy of prematurity grades 3 or 4
(2) Infants with major congenital malformations
(3) Infants with major neurologic disorders (including intraventricular hemorrhage grades 3 or 4 or periventricular leukomalacia).
(4) Infants having had intensive treatments of more than one week because of medical complication such as bacterial infection.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutoshi Cho |
Organization
Hokkaido University Hospital
Division name
Maternity and Perinatal Care Center
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
chotarou@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yousuke Kneshi |
Organization
Hokkaido University Hospital
Division name
Maternity and Perinatal Care Center
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
ness4osuke@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Mental Health, National Center of Neurology and Psychiatry
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 14 | 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
| 2012 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | 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
Management information
Registered date
| 2014 | Year | 08 | Month | 14 | Day |
Last modified on
| 2015 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016834
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
