Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

Study Overview
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Brief Summary
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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.

Official Title
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Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

Conditions
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Hypothyroidism

Intervention / Treatment
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* Drug: iodinated contrast agents


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Iodinated contrast agents<br>children age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination. | Drug: iodinated contrast agents<br>* Intravascular application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting |  | Up to one year after iodinated contrast material (ICM) exposure (828 person years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort |  | 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 |  | At first examination | 
| Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort |  | 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 |  | Prior to first examination | 
| Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without |  | 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 |  | 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 |  | 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 |  | Up to one year after ICM exposure (828 person years) | 
| Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism |  | Up to one year after ICM exposure (828 person years) | 
| The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below. | Up to one year after ICM exposure (828 person years) | 
| The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below. | Up to one year after ICM exposure (828 person years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Iodinated contrast agents