Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Tokyo Women's Medical University

Status: Completed

Conditions: Hypothyroxinemia

Treatments: Drug: thyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT00565890

nrntokyo

T4VLBWI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 4 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 1 patient group

2

No Intervention group

Description:

No replacement therapy

Treatment:

Drug: thyroxine