Skip to main content
OpenTrials
Completed

NCT Number: NCT00565890

Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypothyroxinemia

Age range

2 week–4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternal and Perinatal Center, Tokyo Women's Medical University

Tokyo, 162-8666, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thyroxine

Drug

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

Primary outcomes

  1. Psychomotor development at 1.5 years of age

    Time frame: 18 months

Secondary outcomes

  1. Psychomotor development at 3 years of age

    Time frame: 6 years

  2. Somatic growth at 3 years of age

    Time frame: 6 years

  3. Duration of hospital stay

    Time frame: 6 years

  4. Frequency of morbidities during the stay in NICu

    Time frame: 6 years

Sponsors and collaborators

Lead sponsor

Tokyo Women's Medical University

Other

Collaborators

  • Tokyo Metropolitan Bokuto Hospital

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2013
First posted
Nov 30, 2007
Registry last updated
Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.