Trial Condition(s):
Hypothyroidism
Observational Study on Hypothyroidism in young Children following Iodine Contrast Exposure
Bayer Identifier:
18614
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
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