Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

Completed

• Conditions: Hypothyroidism
• Interventions: Drug: iodinated contrast agents

• Registration Number: NCT02766283
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-09
• Study Start: 2016-06-30
• Primary Completion: 2016-08-30
• Study Completion: 2016-08-30
• Results First Submitted: 2017-08-14
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-20
• Last Update Submitted: 2018-03-20
• Results First Posted: 2018-03-26
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 843

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)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Iodinated contrast agents	iodinated contrast agents	children age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort	At first examination
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 (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
Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism	Up to one year after ICM exposure (828 person years)
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 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)
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)
The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category	Up to one year after ICM exposure (828 person years)	Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.