UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022453 |
|---|---|
| Receipt number | R000025877 |
| Scientific Title | Glucocorticoid production in preterm infants with or without adrenal insufficiency: A cohort study |
| Date of disclosure of the study information | 2016/05/25 |
| Last modified on | 2022/08/09 14:54:57 |
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Basic information
Public title
Glucocorticoid production in preterm infants with or without adrenal insufficiency: A cohort study
Acronym
Glucocorticoid productions in preterm infants
Scientific Title
Glucocorticoid production in preterm infants with or without adrenal insufficiency: A cohort study
Scientific Title:Acronym
Glucocorticoid productions in preterm infants
Region
| Japan |
Condition
Condition
adrenal insufficiency of prematurity
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of 3B-hydroxysteroid dehydrogenase activity among preterm infants with and without adrenal insufficiency
Basic objectives2
Others
Basic objectives -Others
3B-hydroxysteroid dehydrogenase activity and corrected age
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
3B-hydroxysteroid dehydrogenase activity
Key secondary outcomes
correlation between 3B-hydroxysteroid dehydrogenase activity and corrected age
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
| 1 | days-old | <= |
Age-upper limit
| 90 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
preterm infants born before 32 weeks of gestation
Key exclusion criteria
life-threatening morbidities, surgery, major congenital or chromosomal anomalies, symptomatic patent ductus arteriosus, sepsis, necrotizing enterocolitis, or ventricular hemorrhage higher than grade 2
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kusuda |
Organization
Tokyo Women's Medical University
Division name
Maternal and Perinatal Center
Zip code
162-8666
Address
8-1 Kawadacho, Shinjuku, Tokyo 162-8666
TEL
03-5269-7344
skusuda@boshi.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kusuda |
Organization
Tokyo Women's Medical University
Division name
Maternal and Perinatal Center
Zip code
162-8666
Address
8-1 Kawadacho, Shinjuku, Tokyo 162-8666
TEL
03-5269-7344
Homepage URL
skusuda@boshi.twmu.ac.jp
Sponsor or person
Institute
Maternal and Perinatal Center
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Maternal and Perinatal Center
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
8-1 Kawadacho, Shinjuku, Tokyo
Tel
03-3353-8111
kusuda-satoshi@umin.ac.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
東京女子医科大学母子総合医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/30670349/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/30670349/
Number of participants that the trial has enrolled
27
Results
The cortisol concentrations did not differ between the groups before AOP onset (P = 0.20), but the total concentrations of precursors for cortisol were higher in group P (P < 0.0001). The total concentrations of precursors in group C were inversely correlated with postmenstrual age (P < 0.01). The pattern of changes in total concentrations of precursors differed between the groups (P < 0.05).
Results date posted
| 2022 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 12 | Month | 21 | Day |
Baseline Characteristics
Of 27 preterm infants born at less than 32 weeks gestation, cortisol production was analyzed in those who did (patients, group P) and did not (controls, group C) eventually develop late-onset AOP.
Participant flow
Blood samples were prospectively collected every two weeks after birth, and steroid hormone concentrations in the pathway to cortisol production were measured retrospectively.
Adverse events
No
Outcome measures
Trends in serum steroid hormone profiles
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2006 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2006 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Preterm infants born before 32 weeks gestational age who were admitted to Tokyo Women's Medical University NICE between 2006 and 2008 without any exclusion criteria
Serum concentrations of steroid hormones (pregnenolone, 17OHpregnenolone, DHEA, pregnenolone sulfate, 17OHpregnenoloneS, DHEAS, progesterone, 17OHprogesterone, androstenedione, cortisone, and cortisol) were measured every 2 weeks after birth
Compare steroid profiles between infants with and without cortisol supplementation during the stay in NICU
Management information
Registered date
| 2016 | Year | 05 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025877
