UMIN-CTR Clinical Trial

Basic information
Public title	The measurement of the biomarker for diagnosis of th retinopathy of prematurity
Acronym	The biomaker of ROP
Scientific Title	The measurement of the biomarker for diagnosis of th retinopathy of prematurity
Scientific Title:Acronym	The biomaker of ROP
Region	Japan

Condition
Condition	Retinopathy of prematurity
Classification by specialty	Pediatrics Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine relationship between retinopathy of prematurity and tryptase
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We examine relations between tryptase level and onset of the retinopahy of prematurity.
Key secondary outcomes	1.We examine relations between tryptase level and gestational age and birth weight. 2.Postnatal change of the tryptase level. 3.We examine relations between tryptase level and severity of the retinopathy of prematurity.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Pretern infants,less tha 31weeks postconceptional age, who are hospitalized in the neonatal intensive care unit at Tokyo Metropolitan Children's Medical center, Tokyo Metropolitan Bokutoh Hospital and Tokyo Metropolitan Ohtsuka Hospital are eligible for enrollment.Written informed consent was obtained from parent of each neonate.
Key exclusion criteria	1.neonate with chromosomal anomaly 2.neonate with multiple malformation 3.neonate with ophthalmogic abnormality 4.neonate who is judged to be inappropriate as sublect.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masatoshi Middle name Last name Kondo
Organization	Tokyo Metropolitan children's Medical Center
Division name	Department of Neonatology
Zip code	183-8561
Address	2-8-29 Musashidai,Fucyu-shi, tokyo
TEL	042-300-5111
Email	masatoshi_kondou@tmhp.jp

Public contact
Name of contact person	1st name Masatoshi Middle name Last name Kondo
Organization	Tokyo Metropolitan children's Medical Center
Division name	Department of Neonatology
Zip code	183-8561
Address	2-8-29 Musashidai,Fucyu-shi, tokyo
TEL	042-300-5111
Homepage URL
Email	masatoshi_kondou@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan children's Medical Center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan children's Medical Center
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo University of Agriculture and Technology
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Metropolitan children's Medical Center
Address	2-8-29 Musashidai,Fucyu-shi, tokyo
Tel	042-300-5111
Email	sn_chiken-jimu@tmhp.jp

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	東京都立小児総合医療センター(東京都）、東京都立墨東病院(東京都）、東京都立大塚病院(東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2015 Year 09 Month 28 Day
Date of IRB	2015 Year 09 Month 24 Day
Anticipated trial start date	2015 Year 11 Month 07 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2018 Year 04 Month 30 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information	The animal experiment suggests the contribution of mast cells for the onset of the retinopathy of prematurity.

Management information
Registered date	2016 Year 06 Month 13 Day
Last modified on	2019 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026175