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Sponsored by: |
Tokyo Women's Medical University |
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Information provided by: | Tokyo Women's Medical University |
ClinicalTrials.gov Identifier: | NCT00565890 |
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: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-Low-Birth-Weight Infants With Hypothyroxinemia During the First Month of Age |
Estimated Enrollment: | 100 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | January 2010 |
Arms | Assigned Interventions |
---|---|
2: No Intervention
No replacement therapy
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Drug: thyroxine
thyroxine at the dose of 5 μg/kg-wt /day
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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.
Ages Eligible for Study: | up to 4 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Satoshi Kusuda, MD | 03-5269-7344 | skusuda@boshi.twmu.ac.jp |
Contact: Atsushi Uchiyama, MD | 03-3353-8111 ext 28862 | auchiyama12@nifty.com |
Japan | |
Maternal and Perinatal Center, Tokyo Women's Medical University | Recruiting |
Tokyo, Japan, 162-8666 | |
Contact: Satoshi Kusuda, MD 03-5269-7344 skusuda@boshi.twmu.ac.jp | |
Principal Investigator: Satoshi Kusuda, MD |
Principal Investigator: | Satoshi Kusuda, MD | Tokyo Women's Medical Unversity |
Responsible Party: | Maternal and Perinatal Center ( Hiroshi Nishida/Director, Tokyo Women's Medical University ) |
Study ID Numbers: | nrntokyo, T4VLBWI |
Study First Received: | November 29, 2007 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00565890 |
Health Authority: | Japan: Institutional Review Board |
very low birth weight infant hypothyroxinemia outcomes |
Body Weight Birth Weight |