Clinical trial NCT02959827: Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Official title: Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Keywords: Hypothyroidism,
children,
iodinated contrast agents,
retrospective cohort,
database
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-11-09
Enrollment: 2320
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent

Brief summary: This study will estimate the incidence of hypothyroidism in a pediatric population of children under age 4, based on data from the US-based Kaiser Permanente Northern California database, which were exposed to iodinated contrast agent through having a diagnostic procedure.


Eligibility criteria: Inclusion Criteria:

* Children under age 4 in the Kaiser Permanente Northern California (KPNC) database, who had a diagnostic procedure with an iodinated contrast agent.
* Participants should be member of the KPNC for at least 3 months before the iodinated contrast exposure, except where the child is under 3 months of age at time of initial exposure, and 2 weeks after the exposure.

Exclusion Criteria:

* Diagnosis of hypothyroid any time prior to the iodine contrast exposure.
* Lab values for low thyroid (TSH \> 5 mU/L for children) any time before the exposure
* Thyroid replacement therapy, Hashimoto thyroiditis, or congenital hypothyroidism any time prior to exposure.

Primary outcomes:
measure: Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice
timeFrame: In the 365 days post exposure to an iodinated contrast agent
Secondary outcomes:
measure: Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort
timeFrame: Up to 365 days after a diagnostic scan with iodinated contrast agent
measure: Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort
timeFrame: Up to 365 days after a diagnostic scan with iodinated contrast agent
measure: Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort
timeFrame: Up to 365 days after a diagnostic scan with iodinated contrast agent
measure: Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort
timeFrame: Up to 365 days after a diagnostic scan with iodinated contrast agent
measure: Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort
timeFrame: Up to 365 days after a diagnostic scan with iodinated contrast agent
measure: Time From First Iodinated Contrast to First Hypothyroidism Event
timeFrame: Up to 365 days after a diagnostic scan with iodinated contrast agent
measure: Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure
timeFrame: Up to 365 days after a diagnostic scan with iodinated contrast agent
measure: Classification of Hypothyroidism by Etiology
timeFrame: Up to 365 days after a diagnostic scan with iodinated contrast agent
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Oakland
state: California
Study officials:
References: