Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia
Information source: Tokyo Women's Medical University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypothyroxinemia
Intervention: thyroxine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Tokyo Women's Medical University Official(s) and/or principal investigator(s):
Satoshi Kusuda, MD, Principal Investigator, Affiliation: Tokyo Women's Medical Unversity
Overall contact:
Satoshi Kusuda, MD, Phone: 03-5269-7344, Email: skusuda@boshi.twmu.ac.jp
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.
Clinical Details
Official title: Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-Low-Birth-Weight Infants With Hypothyroxinemia During the First Month of Age
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Psychomotor development at 1.5 years of age
Secondary outcome: Psychomotor development at 3 years of ageSomatic growth at 3 years of age Duration of hospital stay Frequency of morbidities during the stay in NICu
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
Minimum age: N/A.
Maximum age: 4 Weeks.
Gender(s): Both.
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
Locations and Contacts
Satoshi Kusuda, MD, Phone: 03-5269-7344, Email: skusuda@boshi.twmu.ac.jp
Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo 162-8666, Japan; Recruiting
Satoshi Kusuda, MD, Phone: 03-5269-7344, Email: skusuda@boshi.twmu.ac.jp
Satoshi Kusuda, MD, Principal Investigator
Additional Information
Starting date: December 2005
Ending date: January 2010
Last updated: November 29, 2007
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