A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years
I2S2
3 other identifiers
interventional
1,275
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2010
Longer than P75 for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2008
CompletedFirst Posted
Study publicly available on registry
March 18, 2008
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 18, 2015
May 1, 2015
5.1 years
March 14, 2008
May 15, 2015
Conditions
Keywords
Outcome Measures
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.
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.
at 2 years corrected age
Secondary Outcomes (16)
Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age.
2 years corrected age
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.
2 years corrected age
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.
2 years corrected age
Type and severity of illness: necrotising enterocolitis
2 years corrected age
Type and severity of illness:persistent ductus arteriosus
2 years corrected age
- +11 more secondary outcomes
Study Arms (2)
Iodine
EXPERIMENTALThis is the hypothetical active arm
Placebo
PLACEBO COMPARATORthis is the hypothetical placebo
Interventions
sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation
Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation
Eligibility Criteria
You may qualify if:
- All infants born under 31 weeks gestation
You may not qualify if:
- Mother exposed to excess iodine during pregnancy or delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- University of Dundeecollaborator
- National Institute for Health Research, United Kingdomcollaborator
Study Sites (19)
Ninewells Hospital and Medical School
Dundee, Tayside, DD1 9SY, United Kingdom
Royal Maternity Hospital
Belfast, BT12 6BB, United Kingdom
Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Derbyshire Childrens Hospital
Derby, DE22 3NE, United Kingdom
Princess Royal Maternity Hospital
Glasgow, G31 2ER, United Kingdom
Southern General Hospital
Glasgow, G51 4TF, United Kingdom
Crosshouse Hospital
Kilmarnock, KA2 0BE, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Altnagelvin Area Hospital
Londonderry, BT47 6SB, United Kingdom
James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PW, United Kingdom
Queen's Medical Centre
Nottingham, NG7 2UH, United Kingdom
Royal Berkshire Hospital
Reading, RG1 5AN, United Kingdom
Jessops Wing Hospital
Sheffield, S10 2SF, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, United Kingdom
Sunderland City Hospitals
Sunderland, SR4 7TP, United Kingdom
Wishaw General Hospital
Wishaw, ML2 0DP, United Kingdom
Related Publications (1)
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.
PMID: 24576827BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fiona Williams, Dr
University of Dundee
- STUDY CHAIR
Peter Brocklehurst, Professor
UCL
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2008
First Posted
March 18, 2008
Study Start
March 1, 2010
Primary Completion
April 1, 2015
Study Completion
May 1, 2015
Last Updated
May 18, 2015
Record last verified: 2015-05