Official Title: “Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-Low-Birth-Weight Infants With Hypothyroxinemia During the First Month of Age”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy 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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 2
  • No replacement therapy

Primary Measures

• Psychomotor development at 1.5 years of age
  • Time Frame: 18 months
    Safety Issue?: Yes

Secondary Measures

• Psychomotor development at 3 years of age
  • Time Frame: 6 years
    Safety Issue?: Yes
• Somatic growth at 3 years of age
  • Time Frame: 6 years
    Safety Issue?: Yes
• Duration of hospital stay
  • Time Frame: 6 years
    Safety Issue?: Yes
• Frequency of morbidities during the stay in NICu
  • Time Frame: 6 years
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 4 Weeks

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Tokyo Women's Medical University

Overall Clinical Trial Officials and Contacts

Satoshi Kusuda, MD Principal Investigator Tokyo Women's Medical Unversity  

Overall Contact: Satoshi Kusuda, MD 03-5269-7344 skusuda@boshi.twmu.ac.jp

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565890

Study ID Number: nrntokyo

ClinicalTrials.gov Identifier: NCT00565890

Health Authority: Japan: Institutional Review Board