Supplemental Thyroxine Treatment for Preterm Infants with Hypothyroxinemia

UMIN ID: UMIN000001953

Registered date:11/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Very low birhth weight infants with thyroxine level less than 0.8 ng/dl at the age of between 2 and 4 weeks after birth
• Date of first enrollment: 2005/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

l-thyroxine 5 microgram/kg/d
no treatment

Outcome(s)

• Primary Outcome: Neurodevelopmental outcome at 1.5 years of corrected age
• Secondary Outcome: Neurodevelopmental outcome at 1.5 years of corrected age Thyroid function Length of stay at NICU Neurodevelopmental outcome at 3 and 6 years of corrected age

Key inclusion & exclusion criteria

• Age minimum: 2weeks-old
• Age maximum: 4weeks-old
• Gender: Male and Female
• Exclude criteria: Maternal thyroid diseases TSH more than 10 microunit/ml Sever congenital malformations

Related Information

• Primary Sponsor: Tokyo Women's Medical University
• Secondary Sponsor: Neonatal group in Tokyo
• Source(s) of Monetary Support: None
• Secondary ID(s): NCT00565890