A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years (I2S2)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Oxford.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Oxford
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
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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 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.
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 ]
| Estimated Enrollment: | 1100 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Iodine
This is the hypothetical active arm
|
Drug: 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
30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
|
Eligibility| Ages Eligible for Study: | up to 42 Hours |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00638092
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638092
Contacts
| 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 |
Locations
| United Kingdom | |
| Ninewells Hospital and Medical School | Recruiting |
| Dundee, Tayside, United Kingdom, DD1 9SY | |
| Contact: Mohammed Ibrahim, Dr m.x.ibrahim@dundee.ac.uk | |
| Principal Investigator: Mohammed Ibrahim, Dr | |
| Royal Maternity Hospital | Recruiting |
| Belfast, United Kingdom, BT12 6BB | |
| Contact: Clifford Mayes clifford.mayes@belfasttrust.hscni.net | |
| Heartlands Hospital | Recruiting |
| Birmingham, United Kingdom, B9 5SS | |
| Contact: Jaideep Singh jaideep.singh@heartofengland.nhs.uk | |
| University Hospital Coventry | Recruiting |
| Coventry, United Kingdom, CV2 2DX | |
| Contact: Prakash Satodia Prakash.Satodia@uhcw.nhs.uk | |
| Derbyshire Childrens Hospital | Recruiting |
| Derby, United Kingdom, DE22 3NE | |
| Contact: John McIntyre john.Mcintyre@derbyhospitals.nhs.uk | |
| Princess Royal Maternity Hospital | Recruiting |
| Glasgow, United Kingdom, G31 2ER | |
| Contact: Andrew Powls andrew.powls@ggc.scot.nhs.uk | |
| Southern General Hospital | Recruiting |
| Glasgow, United Kingdom, G51 4TF | |
| Contact: Lesley Jackson lesley.jackson@ggc.scot.nhs.uk | |
| Crosshouse Hospital | Recruiting |
| Kilmarnock, United Kingdom, KA2 0BE | |
| Contact: Sheena Kinmond sheena.kinmond@aaaht.scot.nhs.uk | |
| Leicester Royal Infirmary | Recruiting |
| Leicester, United Kingdom, LE1 5WW | |
| Contact: Andrew Currie andrew.e.currie@uhl-tr.nhs.uk | |
| Altnagelvin Area Hospital | Recruiting |
| Londonderry, United Kingdom, BT47 6SB | |
| Contact: Mary Ledwidge mary.ledwidge@westhealth.n-i.nhs.uk | |
| James Cook University Hospital | Recruiting |
| Middlesbrough, United Kingdom, TS4 3BW | |
| Contact: Mithilesh Lal mithilesh.lal@stees.nhs.uk | |
| Royal Victoria Infirmary | Recruiting |
| Newcastle Upon Tyne, United Kingdom | |
| Contact: Dr Nick Embleton n.d.embleton@newcastle.ac.uk | |
| Nottingham City Hospital | Recruiting |
| Nottingham, United Kingdom, NG5 1PW | |
| Contact: Jon Dorling jon.dorling@nuh.nhs.net | |
| Queen's Medical Centre | Recruiting |
| Nottingham, United Kingdom, NG7 2UH | |
| Contact: Stephen Wardle stephen.wardle@nuh.nhs.uk | |
| Royal Berkshire Hospital | Recruiting |
| Reading, United Kingdom, RG1 5AN | |
| Contact: Greg Boden greg.boden@royalberkshire.nhs.uk | |
| Jessops Wing Hospital | Recruiting |
| Sheffield, United Kingdom, S10 2SF | |
| Contact: Alan Gibson Alan.gibson@sth.nhs.uk | |
| University Hospital of North Tees | Recruiting |
| Stockton on Tees, United Kingdom | |
| Contact: Dr Chidambara Harikumar chidambara.harikumar@nth.nhs.uk | |
| Sub-Investigator: Dr Samir Gupta | |
| Sunderland City Hospitals | Recruiting |
| Sunderland, United Kingdom, SR4 7TP | |
| Contact: Lorna Gillespie lorna.gilespie@chs.northy.nhs.uk | |
| Wishaw General Hospital | Recruiting |
| Wishaw, United Kingdom, ML2 0DP | |
| Contact: Caroline Delahunty caroline.delahunty@lanarkshire.scot.nhs.uk | |
Sponsors and Collaborators
University of Oxford
University of Dundee
Medical Research Council
Investigators
| Study Director: | Fiona Williams, Dr | University of Dundee | |
| Study Chair: | Peter Brocklehurst, Professor | University of Oxford |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ms Heather House, Clinical Trials and Research Governance, University Of Oxford |
| ClinicalTrials.gov Identifier: | NCT00638092 History of Changes |
| Other Study ID Numbers: | 08/S0501/31, EudraCT Number 2008-001024-31, REC Reference 08/S0501/31 |
| Study First Received: | March 14, 2008 |
| Last Updated: | December 20, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Oxford:
|
hypothyroxinemia preterm iodine neurodevelopmental outcome |
ClinicalTrials.gov processed this record on March 03, 2015