Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,320
- 试验地点
- 1
- 主要终点
- Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Iodinated contrast agents
Children under age 4 in the Kaiser Permanente Northern California database, who had a diagnostic procedure with an iodinated contrast agent
干预措施: Iodinated contrast agents (Drug)
结局指标
主要结局
Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice
时间窗: 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.
次要结局
- 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)