Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia

Not Applicable

Completed

• Conditions: Hypothyroxinemia
• Interventions: Drug: thyroxine

• Registration Number: NCT00565890
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-29
• Study First Posted: 2007-11-30
• Primary Completion: 2011-03
• Status Verified: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• any known thyroid disease in mother

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	thyroxine	No replacement therapy

Primary Outcome Measures

Name	Time	Method
Psychomotor development at 1.5 years of age	18 months

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	6 years
Psychomotor development at 3 years of age	6 years
Somatic growth at 3 years of age	6 years
Frequency of morbidities during the stay in NICu	6 years

Trial Locations

Locations (1)

Maternal and Perinatal Center, Tokyo Women's Medical University; 🇯🇵 Tokyo, Japan