UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050883 |
|---|---|
| Receipt number | R000057727 |
| Scientific Title | Measurement of Histidine-Rich Glycoprotein Levels at birth in Small-for-gestational age. |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/04/20 15:51:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Measurement of Histidine-Rich Glycoprotein Levels at birth in Small-for-gestational age.
Acronym
Measurement of HRG at birth in SGA.
Scientific Title
Measurement of Histidine-Rich Glycoprotein Levels at birth in Small-for-gestational age.
Scientific Title:Acronym
Measurement of HRG at birth in SGA.
Region
| Japan |
Condition
Condition
Small-for-gestational age
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the histidine-rich glycoprotein values of children with small-for-gestational age with those of children with appropriate-for-gestational age.
Basic objectives2
Others
Basic objectives -Others
Blood Protein Dynamics
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the HRG values in SGA infants with those in AGA infants.
Key secondary outcomes
Evaluate the relationship between HRG levels, SGA and oxidative stress.
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
| 5 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Newborn babies born at Okayama University.
Key exclusion criteria
Newborn babies deemed ineligible by the physicians.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Washio |
Organization
Okayama University Hospital
Division name
pediatrics
Zip code
700-8558
Address
2-5-1 Shikatacho, Kita-ku Okayama-shi, Okayama, 700-8558, Japan
TEL
+81-86-235-7249
pediatr@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoka |
| Middle name | |
| Last name | Okamura |
Organization
Okayama University Hospital
Division name
pediatrics
Zip code
700-8558
Address
2-5-1 Shikatacho, Kita-ku Okayama-shi, Okayama, 700-8558, Japan
TEL
+81-86-235-7249
Homepage URL
yes_son39@hotmail.com
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Tomoka Okamura
Funding Source
Organization
None
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
Okayama University Hospital
Address
2-5-1 Shikatacho, Kita-ku Okayama-shi, Okayama, 700-8558, Japan
Tel
+81-86-235-7249
yes_son39@hotmail.com
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Infants born and hospitalized at Okayama University Hospital are performed blood chemical analysis routinely at day 0 and 1. The surplus serum samples are used to measure HRG values. HRG values of SGA and AGA children will be compared.
Management information
Registered date
| 2023 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057727
