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

This study has been completed.
Sponsor:
Collaborators:
University of Dundee
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00638092
First received: March 14, 2008
Last updated: May 15, 2015
Last verified: May 2015

March 14, 2008
May 15, 2015
March 2010
April 2015   (final data collection date for primary outcome 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. [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: No ]
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.
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 ]
  • Type and severity of illness: necrotising enterocolitis [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    Type and severity of illness: necrotising enterocolitis
  • Type and severity of illness:persistent ductus arteriosus [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    Type and severity of illness:persistent ductus arteriosus
  • Type and severity of illness: respiratory distress [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    Type and severity of illness: respiratory distress
  • Type and severity of illness:chronic lung disease (need for oxygen at 36 weeks corrected age) [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    Type and severity of illness: chronic lung disease (need for oxygen at 36 weeks corrected age)
  • Cranial ultrasound changes [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    cranial ultrasound changes
  • Acquired infection [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    Acquired infection as indicated by medical notes during neonatal period
  • Cranial ultrasound changes [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    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.
  • Hearing and vision impairment [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    Hearing and vision impairment as indicated by parental questionnaire
  • Postnatal drug use [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    diamorphine, dexamethasone, dopamine, caffeine and indomethacin
  • Nutritional status [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    Nutritional status collected on postnatal day 7, 14, 28 and 34 corrected weeks (as indicated by neonatal drug chart
  • BAPM level of care [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    BAPM level of care
  • Highest recorded bilirubin levels [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    highest recorded bilirubin levels; and death - immediate and underlying causes.
  • Death - immediate and underlying causes. [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
    Death - immediate and underlying causes.
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.

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.

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
    sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
    Other Name: sodium iodide
  • Drug: Sodium Chloride
    Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
    Other Name: sodium chloride
  • Experimental: Iodine
    This is the hypothetical active arm
    Intervention: Drug: sodium iodide
  • Placebo Comparator: Placebo
    this is the hypothetical placebo
    Intervention: Drug: Sodium Chloride
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1275
May 2015
April 2015   (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 information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00638092
08/S0501/31, 2008-001024-31, 08/S0501/31, 09/800/03
Yes
University of Oxford
University of Oxford
  • University of Dundee
  • National Institute for Health Research, United Kingdom
Study Director: Fiona Williams, Dr University of Dundee
Study Chair: Peter Brocklehurst, Professor UCL
University of Oxford
May 2015

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