UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027480 |
|---|---|
| Receipt number | R000031426 |
| Scientific Title | Plasma concentration of vascular endothelial growth factor in very low birth weight infants at Nagaoka Red Cross hospital |
| Date of disclosure of the study information | 2017/05/25 |
| Last modified on | 2017/05/23 23:35:49 |
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Basic information
Public title
Plasma concentration of vascular endothelial growth factor in very low birth weight infants at Nagaoka Red Cross hospital
Acronym
Plasma concentration of vascular endothelial growth factor in very low birth weight infants at Nagaoka Red Cross hospital
Scientific Title
Plasma concentration of vascular endothelial growth factor in very low birth weight infants at Nagaoka Red Cross hospital
Scientific Title:Acronym
Plasma concentration of vascular endothelial growth factor in very low birth weight infants at Nagaoka Red Cross hospital
Region
| Japan |
Condition
Condition
retinopathy of prematurity
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between vascular endothelial growth factor (VEGF) and ROP by measuring plasma concentration of VEGF in very low birth weight infants at Nagaoka Red Cross hospital.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between vascular endothelial growth factor (VEGF) and ROP by measuring plasma concentration of VEGF in very low birth weight infants at Nagaoka Red Cross hospital.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma concentration of VEGF
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
200 micro litter blood collection every two week
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
very low birth weight infants
Key exclusion criteria
1.Infants that has too severe complications to collect blood samples
2.Infants whom parents decline to collect blood samples
3.Infants that invetigator assess not appropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Yoshino |
Organization
Nagaoka Red Cross Hospital
Division name
Ophthalmology
Zip code
Address
Senshu-2 297-1, Nagaoka-shi, Niigata-ken, Japan
TEL
0258-28-3600
ysnhoph@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Yoshino |
Organization
Nagaoka Red Cross Hospital
Division name
Ophthalmology
Zip code
Address
Senshu-2 297-1, Nagaoka-shi, Niigata-ken, Japan
TEL
0258-28-3600
Homepage URL
ysnhoph@med.niigata-u.ac.jp
Sponsor or person
Institute
Nagaoka Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata university medical and dental hospital
Organization
Division
Category of Funding Organization
Other
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
YES
Study ID_1
2639
Org. issuing International ID_1
Research Ethics Committee, niigata univercity
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 25 | 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
| 2016 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 06 | 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
| 2017 | Year | 05 | Month | 24 | Day |
Last modified on
| 2017 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031426
