Skip to main content
OpenTrials
Completed

NCT Number: NCT00638092

A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Transient Hypothyroxinemia

Age range

1 hour–42 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ninewells Hospital and Medical School, Dundee, Tayside, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All infants born under 31 weeks gestation

Exclusion criteria

  • Mother exposed to excess iodine during pregnancy or delivery

Treatment and study plan

sodium iodide

Drug

sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation

Sodium Chloride

Drug

Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • National Institute for Health Research, United Kingdom
  • University of Dundee

Registry information

Official study title

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

Acronym: I2S2

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2008
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.