A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years (I2S2)

May 15, 2015 updated by: University of Oxford

A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1275

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT12 6BB
        • Royal Maternity Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Heartlands Hospital
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Derby, United Kingdom, DE22 3NE
        • Derbyshire Childrens Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Southern General Hospital
      • Glasgow, United Kingdom, G31 2ER
        • Princess Royal Maternity Hospital
      • Kilmarnock, United Kingdom, KA2 0BE
        • Crosshouse Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Londonderry, United Kingdom, BT47 6SB
        • Altnagelvin Area Hospital
      • Middlesbrough, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle Upon Tyne, United Kingdom
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom, NG7 2UH
        • Queen's Medical Centre
      • Nottingham, United Kingdom, NG5 1PW
        • Nottingham City Hospital
      • Reading, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
      • Sheffield, United Kingdom, S10 2SF
        • Jessops Wing Hospital
      • Stockton on Tees, United Kingdom
        • University Hospital of North Tees
      • Sunderland, United Kingdom, SR4 7TP
        • Sunderland City Hospitals
      • Wishaw, United Kingdom, ML2 0DP
        • Wishaw General Hospital
    • Tayside
      • Dundee, Tayside, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 hour to 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All infants born under 31 weeks gestation

Exclusion Criteria:

  • Mother exposed to excess iodine during pregnancy or delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at 2 years corrected age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age.
Time Frame: 2 years 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.
Time Frame: 2 years corrected age
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.
Time Frame: 2 years corrected age
2 years corrected age
Type and severity of illness: necrotising enterocolitis
Time Frame: 2 years corrected age
Type and severity of illness: necrotising enterocolitis
2 years corrected age
Type and severity of illness:persistent ductus arteriosus
Time Frame: 2 years corrected age
Type and severity of illness:persistent ductus arteriosus
2 years corrected age
Type and severity of illness: respiratory distress
Time Frame: 2 years corrected age
Type and severity of illness: respiratory distress
2 years corrected age
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)
2 years corrected age
Cranial ultrasound changes
Time Frame: 2 years corrected age
cranial ultrasound changes
2 years corrected age
Acquired infection
Time Frame: 2 years corrected age
Acquired infection as indicated by medical notes during neonatal period
2 years corrected age
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.
2 years corrected age
Hearing and vision impairment
Time Frame: 2 years corrected age
Hearing and vision impairment as indicated by parental questionnaire
2 years corrected age
Postnatal drug use
Time Frame: 2 years corrected age
diamorphine, dexamethasone, dopamine, caffeine and indomethacin
2 years corrected age
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
2 years corrected age
BAPM level of care
Time Frame: 2 years corrected age
BAPM level of care
2 years corrected age
Highest recorded bilirubin levels
Time Frame: 2 years corrected age
highest recorded bilirubin levels; and death - immediate and underlying causes.
2 years corrected age
Death - immediate and underlying causes.
Time Frame: 2 years corrected age
Death - immediate and underlying causes.
2 years corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Health Research, United Kingdom
University of Dundee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fiona Williams, Dr, University of Dundee
  • Study Chair: Peter Brocklehurst, Professor, UCL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08/S0501/31 (Other Identifier: REC Reference)
  • 2008-001024-31 (EudraCT Number)
  • 09/800/03 (Other Grant/Funding Number: NIHR EME)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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