This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the required radiologic procedure as part of their standard of care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
17
Isovue will be given to all subjects per the standard of clinical care.
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital and Medical Center
Omaha, Nebraska, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Abnormal Thyroid Function
The primary outcome of this study was to evaluate the proportion of subjects, 0 to 3 years of age, with abnormal TSH values post-baseline following administration of ISOVUE.
Time frame: Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up
Hypothyroidism
To evaluate the proportion of subjects, 0 to 3 years of age, with hypothyroidism regardless of the need for thyroid hormone therapy after administration of ISOVUE.
Time frame: Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up
Thyroid Hormone Replacement Therapy
The proportion of subjects initiated on thyroid hormone replacement therapy.
Time frame: Day 1 (day dosed with intravascular administration of ISOVUE as part of their standard of care examination) to 1-month follow-up or 2-month follow-up to 6- to 12 months follow-up (if applicable)
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