A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years
- Conditions
- Transient Hypothyroxinemia
- Interventions
- Registration Number
- NCT00638092
- Lead Sponsor
- University of Oxford
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1275
- All infants born under 31 weeks gestation
- Mother exposed to excess iodine during pregnancy or delivery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Sodium Chloride this is the hypothetical placebo Iodine sodium iodide This is the hypothetical active arm
- Primary Outcome Measures
Name Time Method Appreciable neurodevelopmental impairment at 2 years corrected age. As measured by the three main domains of the Bayley III score: i.e. cognitive score, language composite score and motor composite score. at 2 years corrected age P ≤0.05 will be the level used to indicate statistical significance.Deaths and those infants with severe neurodevelopment disability will be scored 55 in the cognitive domain, 46 in the motor domain and 47 in the language domain. The primary outcome will be ordered as cognitive score, motor composite score and language composite score in all results presented.
- Secondary Outcome Measures
Name Time Method Hearing and vision impairment 2 years corrected age Hearing and vision impairment as indicated by parental questionnaire
BAPM level of care 2 years corrected age BAPM level of care
Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age. 2 years corrected age Neurodevelopment impairment as a composite of death or a Bayley III score of <85 in any of the score's three main subsets domains: cognitive, language and motor composites. 2 years corrected age Type and severity of illness: necrotising enterocolitis 2 years corrected age Type and severity of illness: necrotising enterocolitis
Type and severity of illness:persistent ductus arteriosus 2 years corrected age Type and severity of illness:persistent ductus arteriosus
Type and severity of illness:chronic lung disease (need for oxygen at 36 weeks corrected age) 2 years corrected age Type and severity of illness: chronic lung disease (need for oxygen at 36 weeks corrected age)
Acquired infection 2 years corrected age Acquired infection as indicated by medical notes during neonatal period
Nutritional status 2 years corrected age Nutritional status collected on postnatal day 7, 14, 28 and 34 corrected weeks (as indicated by neonatal drug chart
Neurodevelopmental impairment assessed as a difference between the iodine supplemented and placebo groups in each of the four subset scores of the Bayley III i.e. receptive communication, expressive communication, fine motor or gross motor. 2 years corrected age Cranial ultrasound changes 2 years corrected age Type and severity of illness: necrotising enterocolitis, persistent ductus arteriosus, respiratory distress , chronic lung disease (need for oxygen at 36 weeks corrected age), cranial ultrasound changes, acquired infection; hearing and vision impairment; postnatal drug use (e.g. diamorphine, dexamethasone, dopamine, caffeine and indomethacin); nutritional status; BAPM level of care; highest recorded bilirubin levels; and death - immediate and underlying causes.
Type and severity of illness: respiratory distress 2 years corrected age Type and severity of illness: respiratory distress
Postnatal drug use 2 years corrected age diamorphine, dexamethasone, dopamine, caffeine and indomethacin
Highest recorded bilirubin levels 2 years corrected age highest recorded bilirubin levels; and death - immediate and underlying causes.
Death - immediate and underlying causes. 2 years corrected age Death - immediate and underlying causes.
Trial Locations
- Locations (19)
Ninewells Hospital and Medical School
🇬🇧Dundee, Tayside, United Kingdom
Royal Maternity Hospital
🇬🇧Belfast, United Kingdom
Heartlands Hospital
🇬🇧Birmingham, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Princess Royal Maternity Hospital
🇬🇧Glasgow, United Kingdom
Derbyshire Childrens Hospital
🇬🇧Derby, United Kingdom
Altnagelvin Area Hospital
🇬🇧Londonderry, United Kingdom
Southern General Hospital
🇬🇧Glasgow, United Kingdom
Crosshouse Hospital
🇬🇧Kilmarnock, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom
Jessops Wing Hospital
🇬🇧Sheffield, United Kingdom
University Hospital of North Tees
🇬🇧Stockton on Tees, United Kingdom
Wishaw General Hospital
🇬🇧Wishaw, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Sunderland City Hospitals
🇬🇧Sunderland, United Kingdom