A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years
NCT ID: NCT00638092
Last Updated: 2015-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1275 participants
INTERVENTIONAL
2010-03-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Iodine
This is the hypothetical active arm
sodium iodide
sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
Placebo
this is the hypothetical placebo
Sodium Chloride
Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
Interventions
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sodium iodide
sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
Sodium Chloride
Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Hour
42 Hours
ALL
No
Sponsors
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University of Dundee
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Fiona Williams, Dr
Role: STUDY_DIRECTOR
University of Dundee
Peter Brocklehurst, Professor
Role: STUDY_CHAIR
UCL
Locations
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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
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
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
Sunderland City Hospitals
Sunderland, , United Kingdom
Wishaw General Hospital
Wishaw, , United Kingdom
Countries
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References
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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.
Related Links
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Supports programme of work
Other Identifiers
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2008-001024-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
08/S0501/31
Identifier Type: OTHER
Identifier Source: secondary_id
09/800/03
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
08/S0501/31
Identifier Type: -
Identifier Source: org_study_id
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