Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

Bayer843 enrolled

Overview

To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice setting.

Study Type

OBSERVATIONAL

Enrollment

843

Conditions

Hypothyroidism

Interventions

iodinated contrast agentsDRUG

Intravascular application

Eligibility

Sex: ALLMax age: 3 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- All children age 0-3 years (inclusive) who are identified of having undergone a radiological examination with intravascular use of an iodinated contrast agent.(e.g. contrast enhanced CT, cardioangiography) Exclusion Criteria: * Congenital Hypothyroidism or other forms of preexisting hypothyroidism * Preexisting thyroid hormone replacement therapy less than three months of observation before the radiological examination (if greater than three months old) * Less than two weeks follow-up available after the contrast exposure.

Locations (1)

Unnamed facility

Multiple Locations, Israel

Outcomes

Primary Outcomes

Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting

Time frame: Up to one year after iodinated contrast material (ICM) exposure (828 person years)

Secondary Outcomes

Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort

Time frame: Up to one year after ICM exposure (828 person years)

Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort

Time frame: At first examination

Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort

Time frame: Within a range of ±360 days of the first examination

Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort

Time frame: Prior to first examination

Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without

Time frame: Up to one year after ICM exposure (828 person years)

Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without

Time frame: Up to one year after ICM exposure (828 person years)

Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without

Time frame: Up to one year after ICM exposure (828 person years)

Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without

Data from ClinicalTrials.gov

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