A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years (I2S2)

University of Oxford

Status and phase: Completed; Phase 4

Conditions: Transient Hypothyroxinemia

Treatments: Drug: sodium iodide; Drug: Sodium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00638092

2008-001024-31 (EudraCT Number)

08/S0501/31 (Other Identifier)

09/800/03 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,275 patients

Sex: All

Ages: 1 to 42 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All infants born under 31 weeks gestation

Exclusion criteria

• Mother exposed to excess iodine during pregnancy or delivery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,275 participants in 2 patient groups, including a placebo group

Iodine

Experimental group

Description:

This is the hypothetical active arm

Treatment:

Drug: sodium iodide

Placebo

Placebo Comparator group

Description:

this is the hypothetical placebo

Treatment:

Drug: Sodium Chloride