UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Supplemental Thyroxine Treatment for Preterm Infants with Hypothyroxinemia
Title of the study (Brief title)	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	Satoshi Kusuda
Organization	Tokyo Women's Medical University
Division name	Dept of Neonatology
Address	8-1 Kawadacho, Shinjuku, Tolyo
TEL	03-3353-8111
Email	kusuda-satoshi@umin.ac.jp

Public contact
Name of contact person	Satoshi Kusuda
Organization	Tokyo Women's Medical University
Division name	Dept of Neonatology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2005 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.degruyter.com/view/j/jpem.2015.28.issue-1-2/jpem-2014-0024/jpem-2014-0024.xml
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.
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/icdr_e/ctr_view.cgi?recptno=R000002381