Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

June 3, 2013 updated by: Satoshi Kusuda, Tokyo Women's Medical University

Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-low-birth-weight Infants With Hypothyroxinemia During the First Month of Age

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 162-8666
        • Maternal and Perinatal Center, Tokyo Women's Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
No replacement therapy
Drug: thyroxine
thyroxine at the dose of 5 μg/kg-wt /day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychomotor development at 3 years of age
Time Frame: 6 years
6 years
Somatic growth at 3 years of age
Time Frame: 6 years
6 years
Duration of hospital stay
Time Frame: 6 years
6 years
Frequency of morbidities during the stay in NICu
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokyo Women's Medical University

Collaborators

Tokyo Metropolitan Bokuto Hospital

Investigators

  • Principal Investigator: Satoshi Kusuda, MD, Tokyo Women's Medical Unversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 29, 2007

First Submitted That Met QC Criteria

November 29, 2007

First Posted (Estimate)

November 30, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nrntokyo
  • T4VLBWI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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