UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001953 |
|---|---|
| Receipt number | R000002381 |
| Scientific Title | Supplemental Thyroxine Treatment for Preterm Infants with Hypothyroxinemia |
| Date of disclosure of the study information | 2009/05/11 |
| Last modified on | 2017/02/23 11:49:41 |
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Basic information
Public title
Supplemental Thyroxine Treatment for Preterm Infants with Hypothyroxinemia
Acronym
Supplemental Thyroxine for preterm infants
Scientific Title
Supplemental Thyroxine Treatment for Preterm Infants with Hypothyroxinemia
Scientific Title:Acronym
Supplemental Thyroxine for preterm infants
Region
| Japan |
Condition
Condition
Very low birhth weight infants with thyroxine level less than 0.8 ng/dl at the age of between 2 and 4 weeks after birth
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the effect of thyroxine supplementation on neuro- and physio-developmental outcome at 3 years of age in very low birthweight infants
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Neurodevelopmental outcome at 1.5 years of corrected age
Key secondary outcomes
Neurodevelopmental outcome at 1.5 years of corrected age
Thyroid function
Length of stay at NICU
Neurodevelopmental outcome at 3 and 6 years of corrected age
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
l-thyroxine 5 microgram/kg/d
Interventions/Control_2
no treatment
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
| 2 | weeks-old | <= |
Age-upper limit
| 4 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
Very low birhth weight infants with thyroxine level less than 0.8 ng/dl at the age of between 2 and 4 weeks after birth
Key exclusion criteria
Maternal thyroid diseases
TSH more than 10 microunit/ml
Sever congenital malformations
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kusuda |
Organization
Tokyo Women's Medical University
Division name
Dept of Neonatology
Zip code
Address
8-1 Kawadacho, Shinjuku, Tolyo
TEL
03-3353-8111
kusuda-satoshi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kusuda |
Organization
Tokyo Women's Medical University
Division name
Dept of Neonatology
Zip code
Address
8-1 Kawadacho, Shinjuku, Tokyo
TEL
03-5269-7344
Homepage URL
kusuda-satoshi@umin.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Neonatal group in Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00565890
Org. issuing International ID_1
ClinicalTrials
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） Tokyo Women's Medical University
都立墨東病院（東京都） Tokyo Metropolitan Bokuto Hospital
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.degruyter.com/view/j/jpem.2015.28.issue-1-2/jpem-2014-0024/jpem-2014-0024.xml
Number of participants that the trial has enrolled
Results
The mean plasma concentrations of FT4 showed no significant differences in the 2 groups, whereas the mean plasma concentration of TSH was significantly lower in the treated group, suggesting suppression of TSH secretion after L-T4 administration (P < 0.05). There were no significant differences in growth at 18 months of corrected age. Furthermore, there were no significant differences in the incidence of developmental delay, cerebral palsy, visual impairment, and hearing impairment.
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
Main results already published
Date of protocol fixation
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 11 | Day |
Last modified on
| 2017 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002381
| 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 |
