Trial Condition(s):
Hypothyroidism
Observational Study on Hypothyroidism in young Children following Iodine Contrast Exposure
Study Completed
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
843
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | ||
|---|---|---|---|
Locations Investigative Site Many Locations, Israel | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Observational Study on Hypothyroidism in young Children following Iodine Contrast Exposure
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of pediatric patients with detected hypothyroidism after iodinated contrast exposure in a routine clinical practice settingTimeframe: Up to one year after ICM exposure (828 person years)
Secondary Outcome
- Baseline characteristics (sex) of the cases with hypothyroidism and of the rest of the cohortTimeframe: Up to one year after ICM exposure (828 person years)
- Baseline characteristics (age) of the cases with hypothyroidism and of the rest of the cohortTimeframe: At first examination
- Baseline characteristics (weight) of the cases with hypothyroidism and of the rest of the cohortTimeframe: Within a range of ±360 days of the first examination
- Baseline characteristics (comorbidity) of the cases with hypothyroidism and of the rest of the cohortTimeframe: Prior to first examination
- Baseline characteristics (sum of examinations) in cases with an indication of hypothyroidism and cases withoutTimeframe: 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 withoutTimeframe: 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 withoutTimeframe: Up to one year after ICM exposure (828 person years)
- Baseline characteristics (time between examinations) in cases with an indication of hypothyroidism and cases withoutTimeframe: Up to one year after ICM exposure (828 person years)
- Time-relation between iodine contrast exposure and diagnosis of hypothyroidismTimeframe: Up to one year after ICM exposure (828 person years)
- The duration of hypothyroidism episode in the “probable iodine induced” categoryBased on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below.Timeframe: Up to one year after ICM exposure (828 person years)
- The duration of hypothyroidism episode in the “probable iodine induced” categoryBased on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.Timeframe: Up to one year after ICM exposure (828 person years)
Additional Information
Copyright © Bayer
Powered by
