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Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Primary Purpose

Hypothyroxinemia

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
thyroxine
Sponsored by
Tokyo Women's Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothyroxinemia focused on measuring very low birth weight infant, hypothyroxinemia, outcomes

Eligibility Criteria

2 Weeks - 4 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maternal and Perinatal Center, Tokyo Women's Medical University

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

2

Arm Description

No replacement therapy

Outcomes

Primary Outcome Measures

Psychomotor development at 1.5 years of age

Secondary Outcome Measures

Psychomotor development at 3 years of age
Somatic growth at 3 years of age
Duration of hospital stay
Frequency of morbidities during the stay in NICu

Full Information

First Posted
November 29, 2007
Last Updated
June 3, 2013
Sponsor
Tokyo Women's Medical University
Collaborators
Tokyo Metropolitan Bokuto Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00565890
Brief Title
Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia
Official Title
Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-low-birth-weight Infants With Hypothyroxinemia During the First Month of Age
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokyo Women's Medical University
Collaborators
Tokyo Metropolitan Bokuto Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroxinemia
Keywords
very low birth weight infant, hypothyroxinemia, outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
No Intervention
Arm Description
No replacement therapy
Intervention Type
Drug
Intervention Name(s)
thyroxine
Intervention Description
thyroxine at the dose of 5 μg/kg-wt /day
Primary Outcome Measure Information:
Title
Psychomotor development at 1.5 years of age
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Psychomotor development at 3 years of age
Time Frame
6 years
Title
Somatic growth at 3 years of age
Time Frame
6 years
Title
Duration of hospital stay
Time Frame
6 years
Title
Frequency of morbidities during the stay in NICu
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satoshi Kusuda, MD
Organizational Affiliation
Tokyo Women's Medical Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternal and Perinatal Center, Tokyo Women's Medical University
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan

12. IPD Sharing Statement

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Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

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