Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

This study has been completed.
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: June 3, 2013
Last verified: June 2013
  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:


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
Study Completion Date: June 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 3, 2013
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 November 23, 2014