A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years (I2S2)

This study is currently recruiting participants.
Verified December 2011 by University of Oxford
Sponsor:
Collaborators:
University of Dundee
Medical Research Council
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00638092
First received: March 14, 2008
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Transient Hypothyroxinemia
Drug: sodium iodide
Drug: sodium chloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Appreciable neurodevelopmental impairment defined as a Bayley III score of <85 in any one of the 3 main domains (cognitive, language and motor domains) [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: No ]
    P ≤0.05 will be the level used to indicate statistical significance.


Secondary Outcome Measures:
  • Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age. [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: March 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iodine
This is the hypothetical active arm
Drug: sodium iodide
30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
Placebo Comparator: Placebo
this is the hypothetical placebo
Drug: sodium chloride
30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation

  Eligibility

Ages Eligible for Study:   up to 42 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All infants born under 31 weeks gestation

Exclusion Criteria:

  • Mother exposed to excess iodine during pregnancy or delivery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638092

Contacts
Contact: Fiona Williams, Dr 01382 420117 f.l.r.williams@chs.dundee.ac.uk
Contact: Kayleigh Morgan, Ms 01865 617923 kayleigh.morgan@npeu.ox.ac.uk

Locations
United Kingdom
Ninewells Hospital and Medical School Recruiting
Dundee, Tayside, United Kingdom, DD1 9SY
Contact: Mohammed Ibrahim, Dr       m.x.ibrahim@dundee.ac.uk   
Principal Investigator: Mohammed Ibrahim, Dr         
Royal Maternity Hospital Recruiting
Belfast, United Kingdom, BT12 6BB
Contact: Clifford Mayes       clifford.mayes@belfasttrust.hscni.net   
Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Contact: Jaideep Singh       jaideep.singh@heartofengland.nhs.uk   
University Hospital Coventry Recruiting
Coventry, United Kingdom, CV2 2DX
Contact: Prakash Satodia       Prakash.Satodia@uhcw.nhs.uk   
Derbyshire Childrens Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Contact: John McIntyre       john.Mcintyre@derbyhospitals.nhs.uk   
Southern General Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Lesley Jackson       lesley.jackson@ggc.scot.nhs.uk   
Princess Royal Maternity Hospital Recruiting
Glasgow, United Kingdom, G31 2ER
Contact: Andrew Powls       andrew.powls@ggc.scot.nhs.uk   
Crosshouse Hospital Recruiting
Kilmarnock, United Kingdom, KA2 0BE
Contact: Sheena Kinmond       sheena.kinmond@aaaht.scot.nhs.uk   
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Contact: Andrew Currie       andrew.e.currie@uhl-tr.nhs.uk   
Altnagelvin Area Hospital Recruiting
Londonderry, United Kingdom, BT47 6SB
Contact: Mary Ledwidge       mary.ledwidge@westhealth.n-i.nhs.uk   
James Cook University Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Mithilesh Lal       mithilesh.lal@stees.nhs.uk   
Royal Victoria Infirmary Recruiting
Newcastle Upon Tyne, United Kingdom
Contact: Dr Nick Embleton       n.d.embleton@newcastle.ac.uk   
Queen's Medical Centre Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Stephen Wardle       stephen.wardle@nuh.nhs.uk   
Nottingham City Hospital Recruiting
Nottingham, United Kingdom, NG5 1PW
Contact: Jon Dorling       jon.dorling@nuh.nhs.net   
Royal Berkshire Hospital Recruiting
Reading, United Kingdom, RG1 5AN
Contact: Greg Boden       greg.boden@royalberkshire.nhs.uk   
Jessops Wing Hospital Recruiting
Sheffield, United Kingdom, S10 2SF
Contact: Alan Gibson       Alan.gibson@sth.nhs.uk   
University Hospital of North Tees Recruiting
Stockton on Tees, United Kingdom
Contact: Dr Chidambara Harikumar       chidambara.harikumar@nth.nhs.uk   
Sub-Investigator: Dr Samir Gupta         
Sunderland City Hospitals Recruiting
Sunderland, United Kingdom, SR4 7TP
Contact: Lorna Gillespie       lorna.gilespie@chs.northy.nhs.uk   
Wishaw General Hospital Recruiting
Wishaw, United Kingdom, ML2 0DP
Contact: Caroline Delahunty       caroline.delahunty@lanarkshire.scot.nhs.uk   
Sponsors and Collaborators
University of Oxford
University of Dundee
Medical Research Council
Investigators
Study Director: Fiona Williams, Dr University of Dundee
Study Chair: Peter Brocklehurst, Professor University of Oxford
  More Information

Additional Information:
No publications provided

Responsible Party: Ms Heather House, Clinical Trials and Research Governance, University Of Oxford
ClinicalTrials.gov Identifier: NCT00638092     History of Changes
Other Study ID Numbers: 08/S0501/31, EudraCT Number 2008-001024-31, REC Reference 08/S0501/31
Study First Received: March 14, 2008
Last Updated: December 20, 2011
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
hypothyroxinemia
preterm
iodine
neurodevelopmental outcome

Additional relevant MeSH terms:
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014