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Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tokyo Metropolitan Bokuto Hospital
Information provided by (Responsible Party):
Satoshi Kusuda, Tokyo Women's Medical University
ClinicalTrials.gov Identifier:
NCT00565890
First received: November 29, 2007
Last updated: December 3, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypothyroxinemia
 Drug: thyroxine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-low-birth-weight Infants With Hypothyroxinemia During the First Month of Age

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Further study details as provided by Tokyo Women's Medical University:

Primary Outcome Measures:
  • Psychomotor development at 1.5 years of age [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Psychomotor development at 3 years of age [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Somatic growth at 3 years of age [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Duration of hospital stay [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Frequency of morbidities during the stay in NICu [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2005
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
No replacement therapy
 Drug: thyroxine
thyroxine at the dose of 5 μg/kg-wt /day

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.

  Eligibility

Ages Eligible for Study:   up to 4 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565890

Locations
Japan
Maternal and Perinatal Center, Tokyo Women's Medical University
Tokyo, Japan, 162-8666
Sponsors and Collaborators
Tokyo Women's Medical University
Tokyo Metropolitan Bokuto Hospital
Investigators
Principal Investigator: Satoshi Kusuda, MD Tokyo Women's Medical Unversity
  More Information

No publications provided

Responsible Party: Satoshi Kusuda, Director, Tokyo Women's Medical University
ClinicalTrials.gov Identifier: NCT00565890     History of Changes
Other Study ID Numbers: nrntokyo, T4VLBWI
Study First Received: November 29, 2007
Last Updated: December 3, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokyo Women's Medical University:
very low birth weight infant
hypothyroxinemia
outcomes

ClinicalTrials.gov processed this record on May 19, 2013