A randomised controlled trial of iodide supplementation in preterm infants with follow-up at 2 years - I2S2 version 1

• Conditions: Transient hyothyroxinaemia; MedDRA version: 14.1Level: LLTClassification code 10043710Term: Thyroid disorder NOSSystem Organ Class: 100000004860

• Registration Number: EUCTR2008-001024-31-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-04
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria Infants who are born under 31 weeks gestation and whose mothers are able to give informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion criteria Infants born at or over 31 weeks gestation. Infants transferred into an I2S2 unit will not be eligible if they or their mother were exposed to povidone-iodine as a skin disinfectant or mother to other sources of excess iodine during pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does iodide supplementation of extreme preterm infants change neurodevelopmental outcome at 2 years corrected age?;Secondary Objective: What is the relationship between supplementation, blood levels of thyroid hormones, illness, drug usage, other events of postnatal period and neurodevelopment?;Primary end point(s): Neurodevelopment at 2 years corrected age. Specifically: The difference of mean Bayley-III MDI score between the arms of the trial' specifically the numbers of infants in each arm of the trial with MDI =85 points i.e. =2 sds . The trial will be analysed under intenion to treat and deaths will be assigned an arbitrary low value. The primary outcome will be reported as 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.