Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Hypothyroxinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565890
• Other study ID #: nrntokyo
• Secondary ID: T4VLBWI
• Status: Completed
• Phase: N/A
• First received: November 29, 2007
• Last updated: June 3, 2013
• Start date: December 2005
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Tokyo Women's Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothyroxinemia

Intervention

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

Locations

Country	Name	City	State
Japan	Maternal and Perinatal Center, Tokyo Women's Medical University	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Tokyo Women's Medical University	Tokyo Metropolitan Bokuto Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychomotor development at 1.5 years of age		18 months	Yes
Secondary	Psychomotor development at 3 years of age		6 years	Yes
Secondary	Somatic growth at 3 years of age		6 years	Yes
Secondary	Duration of hospital stay		6 years	Yes
Secondary	Frequency of morbidities during the stay in NICu		6 years	Yes