UMIN-CTR Clinical Trial

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
Email	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
Email	skusuda@boshi.twmu.ac.jp

Sponsor
Institute	Maternal and Perinatal Center Tokyo Women's Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025877