NCT00638092

A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years

A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,275 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 1 Hour – 42 Hours
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.

Detailed description

Iodine is essential for the synthesis of thyroxine, and thyroxine is essential for normal brain development in utero and for the first 2-3 years of life. The recommended iodine intake in parenteral nutrition regimens is 1 μg/kg/day and commercially available parenteral solutions for infants reflect these recommendations. In the absence of other iodine sources, infants are vulnerable to negative iodine balance and insufficiency. As many preterm infants are fed parenterally for prolonged periods with solutions which have been shown to be iodine-deficient, the I2S2 Trial was designed as a UK multicentre randomised controlled trial to establish whether iodine supplementation of preterm infants benefits neurodevelopment.

Conditions

• Transient Hypothyroxinemia

Interventions

Type	Name	Description
DRUG	sodium iodide	sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
DRUG	Sodium Chloride	Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation

Timeline

• Start date: 2010-03-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2008-03-18
• Last updated: 2015-05-18

Locations

19 sites across 1 country: United Kingdom