UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Plasma concentration of vascular endothelial growth factor in very low birth weight infants at Nagaoka Red Cross hospital
Title of the study (Brief title)	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	Hideaki Yoshino
Organization	Nagaoka Red Cross Hospital
Division name	Ophthalmology
Address	Senshu-2 297-1, Nagaoka-shi, Niigata-ken, Japan
TEL	0258-28-3600
Email	ysnhoph@med.niigata-u.ac.jp

Public contact
Name of contact person	Hideaki Yoshino
Organization	Nagaoka Red Cross Hospital
Division name	Ophthalmology
Address	Senshu-2 297-1, Nagaoka-shi, Niigata-ken, Japan
TEL	0258-28-3600
Homepage URL
Email	ysnhoph@med.niigata-u.ac.jp

Sponsor
Institute	Nagaoka Red Cross Hospital
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 12 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031426