Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

Hypothyroidism Clinical Trial

Official title:

Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766283
• Other study ID #: 18614
• Status: Completed
• First received: May 6, 2016
• Last updated: March 20, 2018
• Start date: June 30, 2016
• Est. completion date: August 30, 2016

Study information

• Verified date: March 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: August 30, 2016
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Drug:
• iodinated contrast agents
Intravascular application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort		At first examination
Secondary	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
Secondary	Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort		Prior to first examination
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism		Up to one year after ICM exposure (828 person years)
Secondary	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)
Secondary	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)

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer products.