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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001953
Receipt No. 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

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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
Email 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
Email kusuda-satoshi@umin.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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