Does the use of an iodine-containing contrast agent to visualise the PICC tip in preterm babies cause hypothyroidism? A randomised controlled trial
Not Applicable
Completed
- Conditions
- Hypothyroidismpremature birthMetabolic and Endocrine - Thyroid diseaseReproductive Health and Childbirth - Complications of newborn
- Registration Number
- ACTRN12614000560695
- Lead Sponsor
- Royal North Shore Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria
Preterms < 30 weeks requiring PICC line after 48 hours of life
Exclusion Criteria
Maternal hypothyroidism/hyperthyroidism
Maternal use of povidone iodine during delivery
Maternal intake of >1100microgram/day Iodine in food or supplements
Maternal intake of antithyroid drugs, Amiodarone
Syndromic babies
Babies on dopamine, steroids, Amiodarone
SGA(small for gestational age) babies(<3rd centile)
Initial abnormal thyroid function test
Neonates having topical povidone iodine exposure
Babies requiring multiple long lines with the previous exposure to contrast
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Hypothyroidism (FT4- < 10pmol/L for any age<br> TSH- > 12mIU/L for any age)<br>[7 and 14 days after injecting contrast]
- Secondary Outcome Measures
Name Time Method ongline tip position identification independently by 2 doctors[Immediately after injecting contrast and xray];Length of impact of iodine on hypothyroidism by doing repeat TFTs on day 21,28,42 and 60.[Maximum 2 months(21,28,42 and 60 days thyroid function tests are done if day 7 or 14 test is abnormal)]