Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure

Bayer

Status: Completed

Conditions: Hypothyroidism

Treatments: Drug: iodinated contrast agents

Study type: Observational

Funder types: Industry

Identifiers

NCT02766283

18614

Details and patient eligibility

About

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.

Enrollment: 843 patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

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.

Trial design

843 participants in 1 patient group

Iodinated contrast agents

Description:

children age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination.

Treatment:

Drug: iodinated contrast agents