NCT02766283已完成不适用
Observational Study on Hypothyroidism in Young Children Following Iodine Contrast Exposure
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 843
- 主要终点
- Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting
研究概览
简要总结
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.
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
- •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)
排除标准
- •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.
研究组 & 干预措施
Iodinated contrast agents
children age 0-3 years (inclusive), who underwent a iodine contrast enhanced radiological examination.
干预措施: iodinated contrast agents (Drug)
结局指标
主要结局
Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting
时间窗: Up to one year after iodinated contrast material (ICM) exposure (828 person years)
次要结局
- Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort(Up to one year after ICM exposure (828 person years))
- Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort(Within a range of ±360 days of the first examination)
- Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort(At first examination)
- Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort(Prior to first examination)
- Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism(Up to one year after ICM exposure (828 person years))
- Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without(Up to one year after ICM exposure (828 person years))
- Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without(Up to one year after ICM exposure (828 person years))
- Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without(Up to one year after ICM exposure (828 person years))
- Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without(Up to one year after ICM exposure (828 person years))
- The Duration of Hypothyroidism Episode in the "Probable Iodine Induced" Category(Up to one year after ICM exposure (828 person years))
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