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Does the use of an iodine-containing contrast agent to visualise the PICC tip in preterm babies cause hypothyroidism? A randomised controlled trial

Does the use of an iodine-containing contrast agent to visualise the PICC tip in preterm babies cause hypothyroidism? A randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000560695
Enrollment
41
Registered
2014-05-26
Start date
2014-11-04
Completion date
2016-12-02
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Preterm babies take time to reach their full quota of oral feeds so often require prolonged intravenous nutrition. Peripheral venous cannulas have a short life span and may result in damage to the skin’s integrity, as well as having a short life span. Long lines or peripherally inserted central catheters(PICC) have a significantly longer life span as the tip is positioned in a large vein.However PICC line insertions are not without complications. The tip of the catheter may reach deep inside the cardiac chambers or fall short of the caval veins and end in entirely unexpected locations. Extravasation of fluid from the catheters in each of these positions has led to serious, and occasionally lethal, complications. These can be avoided if the catheter tip can be precisely localised. The narrow calibre silastic line cannot always be seen on plain radiography but can be visualised with use of a small amount of radio-opaquae contrast. However the contrast available contains Iodine which may cause transient hypothyroidism in newborns. Concerns regarding this have resulted in some units including ours restricting use of contrast when determining line position. The data supporting this decision are very limited and it is unclear as to the role of iodine containing contrast in the development of hypothyroidism. The few studies that have assessed the relationship are either cohort studies, before-and-after study or case series, none being a randomized control trial. The results of these studies are contrasting without any clear answer as to whether perceived benefits of withholding contrast outweigh the risks of developing hypothyroidism. To confuse things further, asymptomatic hypothyroidism is not uncommon in the preterm population. The aim of our study is to compare thyroid function tests in preterm neonates after exposure to IV contrast with controls, to ascertain the impact of a small iodine exposure on the thyroid gland in relation to gestational age. The study will be a randomized control trial for babies less than 30 weeks old requiring insertion of a PICC line. Study infants will be randomised to use of contrast(0.3ml Iopamidol containing iodine 300mg/ml)to assess line position(previous Unit practice) or no contrast. Blood and urine tests will be performed to assess any impact on the thyroid gland of contrast use. Repeat thyroid function tests(TFT) for both case and control will be taken as baseline then 7 and 14days after insertion of the line. Further TFT will be taken if day 7 or 14 results are abnormal.

Interventions

Venous or arterial blood samples 0.5ml to be collected for free Thyroxine( FT4) and Thyroid stimulating hormone( TSH) anytime after 48 hours of life before inserting longline both from case and control. Urine 1-5ml to be collected for iodine/iodine-creatinine ratio anytime after 48 hours of life before inserting longline . Longline is inserted and 0.3ml of contrast iopamidol containing iodine 300mg/ml (ISOVUE 300) taken in a 5ml syringe is injected after the Xray technician comes just before s

Venous or arterial blood samples 0.5ml to be collected for free Thyroxine( FT4) and Thyroid stimulating hormone( TSH) anytime after 48 hours of life before inserting longline both from case and control. Urine 1-5ml to be collected for iodine/iodine-creatinine ratio anytime after 48 hours of life before inserting longline . Longline is inserted and 0.3ml of contrast iopamidol containing iodine 300mg/ml (ISOVUE 300) taken in a 5ml syringe is injected after the Xray technician comes just before shooting in case only. Urine 1-5ml for iodine should be collected between 1-8 hours after injecting contrast . Repeat FT4 and TSH 7, 14days after insertion of line. (21,28,42 and 60 days thyroid function tests( TFTs) are done if day 7 or 14 test result is abnormal.)

Sponsors

Royal North Shore Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
48 Hours to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026