Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

NCT ID: NCT00565890

Last Updated: 2013-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Hypothyroxinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2

No replacement therapy

Group Type NO_INTERVENTION

thyroxine

Intervention Type DRUG

thyroxine at the dose of 5 μg/kg-wt /day

Interventions

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thyroxine

thyroxine at the dose of 5 μg/kg-wt /day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokyo Metropolitan Bokuto Hospital

UNKNOWN

Sponsor Role collaborator

Tokyo Women's Medical University

OTHER

Sponsor Role lead

Responsible Party

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Satoshi Kusuda

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Satoshi Kusuda, MD

Role: PRINCIPAL_INVESTIGATOR

Tokyo Women's Medical Unversity

Locations

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Maternal and Perinatal Center, Tokyo Women's Medical University

Tokyo, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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T4VLBWI

Identifier Type: -

Identifier Source: secondary_id

nrntokyo

Identifier Type: -

Identifier Source: org_study_id

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