UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022720 |
|---|---|
| Receipt number | R000026175 |
| Scientific Title | The measurement of the biomarker for diagnosis of th retinopathy of prematurity |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2019/06/17 09:36:17 |
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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
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
masatoshi_kondou@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan children's Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026175
| 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 |
