This trial has been completed.

Condition hypothyroidism
Treatment iodinated contrast agents
Sponsor Bayer
Start date June 2016
End date August 2016
Trial size 843 participants
Trial identifier NCT02766283, 18614


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
children age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination.
iodinated contrast agents
Intravascular application

Primary Outcomes

Number of pediatric patients with detected hypothyroidism after iodinated contrast exposure in a routine clincial practice setting.
time frame: Up to one year after exposure

Eligibility Criteria

Male or female participants up to 3 years old.

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.

Additional Information

Official title Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.