A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years (I2S2)
This study has been completed.
Sponsor:
University of Oxford
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
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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 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.
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 ]
- 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.
| Enrollment: | 1275 |
| Study Start Date: | March 2010 |
| Study Completion Date: | May 2015 |
| Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | up to 42 Hours (Child) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638092
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638092
Locations
| United Kingdom | |
| Ninewells Hospital and Medical School | |
| Dundee, Tayside, United Kingdom, DD1 9SY | |
| Royal Maternity Hospital | |
| Belfast, United Kingdom, BT12 6BB | |
| Heartlands Hospital | |
| Birmingham, United Kingdom, B9 5SS | |
| University Hospital Coventry | |
| Coventry, United Kingdom, CV2 2DX | |
| Derbyshire Childrens Hospital | |
| Derby, United Kingdom, DE22 3NE | |
| Princess Royal Maternity Hospital | |
| Glasgow, United Kingdom, G31 2ER | |
| Southern General Hospital | |
| Glasgow, United Kingdom, G51 4TF | |
| Crosshouse Hospital | |
| Kilmarnock, United Kingdom, KA2 0BE | |
| Leicester Royal Infirmary | |
| Leicester, United Kingdom, LE1 5WW | |
| Altnagelvin Area Hospital | |
| Londonderry, United Kingdom, BT47 6SB | |
| James Cook University Hospital | |
| Middlesbrough, United Kingdom, TS4 3BW | |
| Royal Victoria Infirmary | |
| Newcastle Upon Tyne, United Kingdom | |
| Nottingham City Hospital | |
| Nottingham, United Kingdom, NG5 1PW | |
| Queen's Medical Centre | |
| Nottingham, United Kingdom, NG7 2UH | |
| Royal Berkshire Hospital | |
| Reading, United Kingdom, RG1 5AN | |
| Jessops Wing Hospital | |
| Sheffield, United Kingdom, S10 2SF | |
| University Hospital of North Tees | |
| Stockton on Tees, United Kingdom | |
| Sunderland City Hospitals | |
| Sunderland, United Kingdom, SR4 7TP | |
| Wishaw General Hospital | |
| Wishaw, United Kingdom, ML2 0DP | |
Sponsors and Collaborators
University of Oxford
University of Dundee
National Institute for Health Research, United Kingdom
Investigators
| Study Director: | Fiona Williams, Dr | University of Dundee |
| Study Chair: | Peter Brocklehurst, Professor | UCL |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT00638092 History of Changes |
| Other Study ID Numbers: | 08/S0501/31 2008-001024-31 08/S0501/31 09/800/03 |
| Study First Received: | March 14, 2008 |
| Last Updated: | May 15, 2015 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Oxford:
|
hypothyroxinemia preterm infants iodine |
neurodevelopmental outcome Iodine supplementation Randomised controlled trial |
Additional relevant MeSH terms:
|
Iodine Anti-Infective Agents, Local Anti-Infective Agents Trace Elements |
Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 29, 2016