Clinical trial NCT00638092: A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years
Official title: A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transient Hypothyroxinemia
Keywords: hypothyroxinemia
preterm infants
iodine
neurodevelopmental outcome
Iodine supplementation
Randomised controlled trial
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: University of Dundee
name: National Institute for Health Research, United Kingdom
First posted: 2008-03-18
Enrollment: 1275
Sex: ALL
Minimum age (years): 1
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* All infants born under 31 weeks gestation

Exclusion Criteria:

* Mother exposed to excess iodine during pregnancy or delivery

Primary outcomes:
measure: 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.
timeFrame: at 2 years corrected age
Secondary outcomes:
measure: Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age.
timeFrame: 2 years corrected age
measure: 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.
timeFrame: 2 years corrected age
measure: 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.
timeFrame: 2 years corrected age
measure: Type and severity of illness: necrotising enterocolitis
timeFrame: 2 years corrected age
measure: Type and severity of illness:persistent ductus arteriosus
timeFrame: 2 years corrected age
measure: Type and severity of illness: respiratory distress
timeFrame: 2 years corrected age
measure: Type and severity of illness:chronic lung disease (need for oxygen at 36 weeks corrected age)
timeFrame: 2 years corrected age
measure: Cranial ultrasound changes
timeFrame: 2 years corrected age
measure: Acquired infection
timeFrame: 2 years corrected age
measure: Cranial ultrasound changes
timeFrame: 2 years corrected age
measure: Hearing and vision impairment
timeFrame: 2 years corrected age
measure: Postnatal drug use
timeFrame: 2 years corrected age
measure: Nutritional status
timeFrame: 2 years corrected age
measure: BAPM level of care
timeFrame: 2 years corrected age
measure: Highest recorded bilirubin levels
timeFrame: 2 years corrected age
measure: Death - immediate and underlying causes.
timeFrame: 2 years corrected age
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Tayside
city: Belfast
country: United Kingdom
facility: Royal Maternity Hospital
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Derby
country: United Kingdom
facility: Derbyshire Childrens Hospital
city: Glasgow
country: United Kingdom
facility: Princess Royal Maternity Hospital
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
city: Kilmarnock
country: United Kingdom
facility: Crosshouse Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
city: Sheffield
country: United Kingdom
facility: Jessops Wing Hospital
city: Stockton on Tees
country: United Kingdom
facility: University Hospital of North Tees
city: Sunderland
country: United Kingdom
facility: Sunderland City Hospitals
city: Wishaw
country: United Kingdom
facility: Wishaw General Hospital
Study officials:
affiliation: University of Dundee
name: Fiona Williams, Dr
role: STUDY_DIRECTOR
affiliation: UCL
name: Peter Brocklehurst, Professor
role: STUDY_CHAIR
References:
citation: Williams F, Hume R, Ogston S, Brocklehurst P, Morgan K, Juszczak E; I2S2 team. A summary of the iodine supplementation study protocol (I2S2): a UK multicentre randomised controlled trial in preterm infants. Neonatology. 2014;105(4):282-9. doi: 10.1159/000358247. Epub 2014 Feb 27.