Effect of iodine dye injected into long central venous catheter, on Thyroid Function in Premature Infants

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Premature babies admitted to neonatal intensive care units routinely undergo insertion of Peripherally Inserted Central venous Catheter (PICC) lines. It is a routine practice to perform x-ray to visualise the line tip to ensure it is in the ideal location. There is a varied practice in different NICUs in Australia, with some NICUs including Nepean Hospital NICU routinely injecting iodine containing dye to enhance visibility of PICC tip on x-ray. Exposure to high doses of iodine potentially increases the risk of hypothyroidism. Although the hypothyroidism due to iodine is likely transient, the effects during the critical period of neurological development in premature babies are potentially detrimental. There is paucity of evidence from randomised controlled study regarding the potential benefits and risks of using iodine-containing intravenous contrast in PICC insertions in premature babies. Thus, a study examining these outcomes in neonates with a placebo-controlled group is urgently required. Design: double-blind RCT. Infants eligible for 28 G PICC line will be enrolled following parental consent. Participants will be excluded from the PITFALLS study should they be: Infants with diagnosed thyroid disorders, Born to mothers with thyroid disease with potential to influence fetal thyroid function, Infants being given iodine iodine-containing contrast for some other reason, PICC inserted for the second /subsequent times in an infant who was already enrolled once, Anuria, Severe decompensated cardiac failure, Major lethal congenital/chromosomal anomalies. Babies will be randomised to receive the study agent(iodine dye or normal saline). Treatment allocation will be made by the method of stratified block randomisation using computer generated codes. Randomisation will be done by the clinical trials pharmacist, soon after successful insertion of the PICC. All others will be blinded. Treatment arm will receive 0.2 mL water-soluble, non-ionic, iodine-containing agent iohexol [Omnipaque (Trademark) 180, GE Healthcare, Little Chalfont, UK] through PICC line during X-ray. Control arm will receive 0.2 mL normal saline through PICC line during X-ray. Both these agents will be prepared in identical looking syringes in the Pharmacy and labelled as Study agent. Only the clinical trials pharmacist will be aware of the agent and will not be involved in the study. Researchers will be blinded as to what study agent is being administered to infants. Primary outcome: fT4 and TSH in controls and exposed. Primary end points: fT4 and TSH before PICC line insertion and subsequently on a weekly basis for next 4 weeks Secondary outcome: Clearly identifiable tip position of PICC on X-ray Secondary end point: Following successful insertion of PICC line Sample size: 60

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