I2S2 - Iodine supplementation trial - iodine supplementation for premature babies
- Principal investigators
- Fiona Williams (University of Dundee), Peter Brocklehurst (NPEU)
- Collaborators
- Peter Willatts (University of Dundee), Theo Visser (Erasmus University, Brussels, Belgium), Simon Ogston (University of Dundee), Robert Hume (University of Dundee)
- Topics
- Care of the preterm or low birthweight infant, Preterm birth
- Funder
- Economic and Social Research Council
- Start year
- 2015
- End year
- 2009
- NPEU Contact
- Ed Juszczak
Summary
Cerebral damage and neurodisability are common among extremely preterm infants who survive, and there are about 7,000 such infants born each year in the UK. The aetiology of this cerebral damage and neurodisability is multifactorial, and is associated with a number of factors including hypothyroxinaemia. Thyroid hormone is essential for normal development of the human brain in utero and for the first two years after birth; damage through deficiency of thyroxine is irreversible. Transient hypothyroxinaemia in preterm infants is common and studies have linked low plasma T4 in preterm infants with later neurodevelopmental deficits in motor and cognitive function. Iodine is essential for the synthesis of T4. Mild and moderate deficiencies of iodine are associated with neuropsychointellectual deficits in infants and children.
Funded by the UK Medical Research Council (MRC) and designed in collaboration with the University of Dundee, the I2S2 trial is a multi-centre randomised controlled trial of iodine supplementation in extreme preterm infants. It aims to answer whether iodine supplementation of parenterally or enterally extremely preterm fed infants can improve neurodevelopmental outcome at 2 years corrected age.
Publications
Journal Articles
- Morgan K, Juszczak E, Bowler U. A practical solution to 'Continuing Care site' issues in neonatal clinical trials - a pragmatic approach to regulatory and research governance review. Trials. 2011;12(Supp 1):A37.
- Williams F, Hume R, Ogston S, Brocklehurst P, Morgan K, Juszczak E. A Summary of the Iodine Supplementation Study Protocol (I2S2): A UK Multicentre Randomised Controlled Trial in Preterm Infants. Neonatology. 2014;105(4):282-9.
- Williams FLR, Ogston S, Hume R, Watson J, Stanbury K, Willatts P, Boelen A, Juszczak E, Brocklehurst P. Supplemental Iodide for Preterm Infants and Developmental Outcomes at 2 Years: An RCT. Pediatrics. 2017;139(5).