Trial | NCT00565890  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
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 Started
Dec 31
2005
Primary Completion
Mar 31
2011
Study Completion
Jun 30
2013
Last Update
Jun 04
2013
Estimate

Drug thyroxine

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

2 No Intervention

No replacement therapy

Criteria 

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
No Results Posted