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

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ClinicalTrials.gov Identifier: NCT00638092
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : May 18, 2015
Sponsor:
Collaborators:
University of Dundee
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Transient Hypothyroxinemia Drug: sodium iodide Drug: Sodium Chloride Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years
Study Start Date : March 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Iodine
This is the hypothetical active arm
Drug: sodium iodide
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
Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age. [ Time Frame: 2 years corrected age ]
  2. 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 ]
  3. 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 ]
  4. Type and severity of illness: necrotising enterocolitis [ Time Frame: 2 years corrected age ]
    Type and severity of illness: necrotising enterocolitis

  5. Type and severity of illness:persistent ductus arteriosus [ Time Frame: 2 years corrected age ]
    Type and severity of illness:persistent ductus arteriosus

  6. Type and severity of illness: respiratory distress [ Time Frame: 2 years corrected age ]
    Type and severity of illness: respiratory distress

  7. Type and severity of illness:chronic lung disease (need for oxygen at 36 weeks corrected age) [ Time Frame: 2 years corrected age ]
    Type and severity of illness: chronic lung disease (need for oxygen at 36 weeks corrected age)

  8. Cranial ultrasound changes [ Time Frame: 2 years corrected age ]
    cranial ultrasound changes

  9. Acquired infection [ Time Frame: 2 years corrected age ]
    Acquired infection as indicated by medical notes during neonatal period

  10. Cranial ultrasound changes [ Time Frame: 2 years corrected age ]
    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.

  11. Hearing and vision impairment [ Time Frame: 2 years corrected age ]
    Hearing and vision impairment as indicated by parental questionnaire

  12. Postnatal drug use [ Time Frame: 2 years corrected age ]
    diamorphine, dexamethasone, dopamine, caffeine and indomethacin

  13. Nutritional status [ Time Frame: 2 years corrected age ]
    Nutritional status collected on postnatal day 7, 14, 28 and 34 corrected weeks (as indicated by neonatal drug chart

  14. BAPM level of care [ Time Frame: 2 years corrected age ]
    BAPM level of care

  15. Highest recorded bilirubin levels [ Time Frame: 2 years corrected age ]
    highest recorded bilirubin levels; and death - immediate and underlying causes.

  16. Death - immediate and underlying causes. [ Time Frame: 2 years corrected age ]
    Death - immediate and underlying causes.



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Ages Eligible for Study:   up to 42 Hours   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638092


Locations
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Sponsors and Collaborators
University of Oxford
University of Dundee
National Institute for Health Research, United Kingdom
Investigators
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Study Director: Fiona Williams, Dr University of Dundee
Study Chair: Peter Brocklehurst, Professor UCL
Additional Information:
Publications:
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT00638092    
Other Study ID Numbers: 08/S0501/31
2008-001024-31 ( EudraCT Number )
08/S0501/31 ( Other Identifier: REC Reference )
09/800/03 ( Other Grant/Funding Number: NIHR EME )
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: May 2015
Keywords provided by University of Oxford:
hypothyroxinemia
preterm infants
iodine
neurodevelopmental outcome
Iodine supplementation
Randomised controlled trial
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications