MedTrace Logo

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

NCT00638092 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1275

Last updated 2015-05-18

No results posted yet for this study

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.

Conditions

  • Transient Hypothyroxinemia

Interventions

DRUG

sodium iodide

sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation

DRUG

Sodium Chloride

Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation

Sponsors & Collaborators

  • University of Dundee

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Principal Investigators

  • Fiona Williams, Dr · University of Dundee

  • Peter Brocklehurst, Professor · UCL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
42 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2015-04-30
Completion
2015-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00638092 on ClinicalTrials.gov