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Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Information source: Tokyo Women's Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypothyroxinemia

Intervention: thyroxine (Drug)

Phase: N/A

Status: Completed

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

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Psychomotor development at 1.5 years of age

Secondary outcome:

Psychomotor development at 3 years of age

Somatic 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

Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo 162-8666, Japan
Additional Information

Starting date: December 2005
Last updated: June 3, 2013

Page last updated: August 23, 2015

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