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

This study is currently recruiting participants. (see Contacts and Locations)
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

March 14, 2008
December 20, 2011
March 2010
June 2012   (final data collection date for primary outcome measure)
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.
neurodevelopment status [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00638092 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
Not Provided
 
A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years
A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Transient Hypothyroxinemia
  • Drug: sodium iodide
    30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
  • Drug: sodium chloride
    30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
  • Experimental: Iodine
    This is the hypothetical active arm
    Intervention: Drug: sodium iodide
  • Placebo Comparator: Placebo
    this is the hypothetical placebo
    Intervention: Drug: sodium chloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1100
March 2015
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All infants born under 31 weeks gestation

Exclusion Criteria:

  • Mother exposed to excess iodine during pregnancy or delivery
Both
up to 42 Hours
No
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
United Kingdom
 
NCT00638092
08/S0501/31, EudraCT Number 2008-001024-31, REC Reference 08/S0501/31
Yes
Ms Heather House, Clinical Trials and Research Governance, University Of Oxford
University of Oxford
  • University of Dundee
  • Medical Research Council
Study Director: Fiona Williams, Dr University of Dundee
Study Chair: Peter Brocklehurst, Professor University of Oxford
University of Oxford
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP