A pilot study to inform a randomised controlled trial of iodine supplementation in preterm infants - iodine rct
Phase 1
- Conditions
- transient hypothyroxinaemia
- Registration Number
- EUCTR2005-002404-42-GB
- Lead Sponsor
- niversity of Dundee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
infants born =<30weeks gestation
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Infants born over 30 weeks gestation. Mothers and infants will be excluded from the study if they are known to be viral hepatitis/HIV positive, have problems giving consent because of mental illness or communication difficulties. Infants with serious congenital anomaly will be excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1.We aim to determine whether enteral supplementation with iodine is effective in promoting a positive iodine balance in extreme preterm infants who are parenterally fed.<br>2.To determine the efficacy of the oral versus the nasogastric route of iodine supplementation<br>;Secondary Objective: none;Primary end point(s): iodine balance at postnatal days 7, 14, 28
- Secondary Outcome Measures
Name Time Method