NCT00565890

Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tokyo Women's Medical University · Academic / Other
• Sex: All
• Age: 2 Weeks – 4 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Hypothyroxinemia

Interventions

Type	Name	Description
DRUG	thyroxine	thyroxine at the dose of 5 μg/kg-wt /day

Timeline

• Start date: 2005-12-01
• Primary completion: 2011-03-01
• Completion: 2013-06-01
• First posted: 2007-11-30
• Last updated: 2013-06-04

Locations

1 site across 1 country: Japan