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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,275
sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
Ninewells Hospital and Medical School
Dundee, Tayside, United Kingdom
Royal Maternity Hospital
Belfast, United Kingdom
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.
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.
Time frame: at 2 years corrected age
Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age.
Time frame: 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.
Time frame: 2 years corrected age
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.
Time frame: 2 years corrected age
Type and severity of illness: necrotising enterocolitis
Type and severity of illness: necrotising enterocolitis
Time frame: 2 years corrected age
Type and severity of illness:persistent ductus arteriosus
Type and severity of illness:persistent ductus arteriosus
Time frame: 2 years corrected age
Type and severity of illness: respiratory distress
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Heartlands Hospital
Birmingham, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Derbyshire Childrens Hospital
Derby, United Kingdom
Princess Royal Maternity Hospital
Glasgow, United Kingdom
Southern General Hospital
Glasgow, United Kingdom
Crosshouse Hospital
Kilmarnock, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Altnagelvin Area Hospital
Londonderry, United Kingdom
...and 9 more locations
Type and severity of illness: respiratory distress
Time frame: 2 years corrected age
Type and severity of illness:chronic lung disease (need for oxygen at 36 weeks corrected age)
Type and severity of illness: chronic lung disease (need for oxygen at 36 weeks corrected age)
Time frame: 2 years corrected age
Cranial ultrasound changes
cranial ultrasound changes
Time frame: 2 years corrected age
Acquired infection
Acquired infection as indicated by medical notes during neonatal period
Time frame: 2 years corrected age
Cranial ultrasound changes
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.
Time frame: 2 years corrected age
Hearing and vision impairment
Hearing and vision impairment as indicated by parental questionnaire
Time frame: 2 years corrected age
Postnatal drug use
diamorphine, dexamethasone, dopamine, caffeine and indomethacin
Time frame: 2 years corrected age
Nutritional status
Nutritional status collected on postnatal day 7, 14, 28 and 34 corrected weeks (as indicated by neonatal drug chart
Time frame: 2 years corrected age
BAPM level of care
BAPM level of care
Time frame: 2 years corrected age
Highest recorded bilirubin levels
highest recorded bilirubin levels; and death - immediate and underlying causes.
Time frame: 2 years corrected age
Death - immediate and underlying causes.
Death - immediate and underlying causes.
Time frame: 2 years corrected age