Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

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 Overview

• Status: Completed
• Conditions: Hypothyroidism
• Intervention / Treatment: Drug: iodinated contrast agents

• Study Type: Observational
• Enrollment (Actual): 843

Contacts and Locations

Study Locations

• Israel
  • Multiple Locations, Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Members of Maccabi Health Services database (Israel)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Iodinated contrast agents; children age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination.	Drug: iodinated contrast agents; Intravascular application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2016
• Primary Completion (ACTUAL): August 30, 2016
• Study Completion (ACTUAL): August 30, 2016

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (ESTIMATE): May 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Children; Iodinated contrast agents
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: 18614

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No