Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Tokyo Women's Medical University100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Hypothyroxinemia

Interventions

thyroxineDRUG

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

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 4 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Maternal and Perinatal Center, Tokyo Women's Medical University

Tokyo, Tokyo, Japan

Outcomes

Primary Outcomes

Psychomotor development at 1.5 years of age

Time frame: 18 months

Secondary Outcomes

Psychomotor development at 3 years of age

Time frame: 6 years

Somatic growth at 3 years of age

Time frame: 6 years

Duration of hospital stay

Time frame: 6 years

Frequency of morbidities during the stay in NICu

Time frame: 6 years

Data from ClinicalTrials.gov

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