Supplemental Thyroxine Treatment for Preterm Infants With... | NCT00565890

Studies
Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

NCT00565890

Sponsor

Tokyo Women's Medical University

Status

Completed

Last Update Posted

Jun 4, 2013Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Hypothyroxinemia

Interventions

thyroxine

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
T4VLBWI

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Mar 2011Actual

Completion Date

Jun 2013Actual

First Submitted Date

Nov 29, 2007

First Submission Date that Met QC Criteria

Nov 29, 2007

First Posted Date

Nov 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2013

Last Update Posted Date

Jun 4, 2013Estimated

Name	Class
Tokyo Metropolitan Bokuto Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.

Detailed Description

A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	No Intervention	No replacement therapy	Drug: thyroxine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
thyroxine	Drug	thyroxine at the dose of 5 μg/kg-wt /day	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychomotor development at 1.5 years of age		18 months

Secondary Outcomes

Measure	Description	Time Frame
Psychomotor development at 3 years of age		6 years
Somatic growth at 3 years of age		6 years
Duration of hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Birth weight: less than 1500g
Gestation: 22 weeks 0 day ≤
Serum free thyroxine level lower than 0.8 ng/dl
Serum thyrotropin lower than 10 μU/ml
Age of between 2 and 4 weeks after birth
Informed consent

Exclusion Criteria:

any known thyroid disease in mother

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Weeks

Maximum Age

4 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Satoshi Kusuda, MD	Tokyo Women's Medical Unversity	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maternal and Perinatal Center, Tokyo Women's Medical University		Tokyo	Tokyo	162-8666	Japan

Intervention Browse Module

MeSH Terms

ID	Term
D013974	Thyroxine

Ancestor Terms

ID	Term
D013963	Thyroid Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D024322	Amino Acids, Aromatic

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Browse Branches

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