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Clinical Trials/NCT02959827
NCT02959827CompletedNot Applicable

Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States

Bayer1 site in 1 country2,320 target enrollmentStarted: October 15, 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Bayer
Enrollment
2,320
Locations
1
Primary Endpoint
Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
— to 3 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Iodinated contrast agents

Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent

Intervention: Iodinated contrast agents (Drug)

Outcomes

Primary Outcomes

Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice

Time Frame: In the 365 days post exposure to an iodinated contrast agent

Incidence density rates (IDR) were calculated as the number of cases over the person time at risk where the numerator was the number of cases and the denominator was the person years at risk.

Secondary Outcomes

  • Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)
  • Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure(Up to 365 days after a diagnostic scan with iodinated contrast agent)
  • Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)
  • Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)
  • Time From First Iodinated Contrast to First Hypothyroidism Event(Up to 365 days after a diagnostic scan with iodinated contrast agent)
  • Classification of Hypothyroidism by Etiology(Up to 365 days after a diagnostic scan with iodinated contrast agent)
  • Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)
  • Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to 365 days after a diagnostic scan with iodinated contrast agent)

Investigators

Sponsor
Bayer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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