Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565890
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : June 4, 2013
Tokyo Metropolitan Bokuto Hospital
Information provided by (Responsible Party):
Satoshi Kusuda, Tokyo Women's Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypothyroxinemia Drug: thyroxine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2005
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 2
No replacement therapy
Drug: thyroxine
thyroxine at the dose of 5 μg/kg-wt /day

Primary Outcome Measures :
  1. Psychomotor development at 1.5 years of age [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Psychomotor development at 3 years of age [ Time Frame: 6 years ]
  2. Somatic growth at 3 years of age [ Time Frame: 6 years ]
  3. Duration of hospital stay [ Time Frame: 6 years ]
  4. Frequency of morbidities during the stay in NICu [ Time Frame: 6 years ]

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00565890

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

Responsible Party: Satoshi Kusuda, Director, Tokyo Women's Medical University Identifier: NCT00565890     History of Changes
Other Study ID Numbers: nrntokyo
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Keywords provided by Satoshi Kusuda, Tokyo Women's Medical University:
very low birth weight infant