check_circleStudy Completed
Hypothyroidism
Bayer Identifier:
18614
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Observational Study on Hypothyroidism in young Children following Iodine Contrast Exposure
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.
Key Participants Requirements
Sex
BothAge
0 - 3 YearsTrial summary
Enrollment Goal
843Trial Dates
June 2016 - August 2016Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Israel |
Primary Outcome
- Number of pediatric patients with detected hypothyroidism after iodinated contrast exposure in a routine clinical practice settingdate_rangeTime Frame:Up to one year after ICM exposure (828 person years)enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Baseline characteristics (sex) of the cases with hypothyroidism and of the rest of the cohortdate_rangeTime Frame:Up to one year after ICM exposure (828 person years)enhanced_encryptionNoSafety Issue:
- Baseline characteristics (age) of the cases with hypothyroidism and of the rest of the cohortdate_rangeTime Frame:At first examinationenhanced_encryptionNoSafety Issue:
- Baseline characteristics (weight) of the cases with hypothyroidism and of the rest of the cohortdate_rangeTime Frame:Within a range of ±360 days of the first examinationenhanced_encryptionNoSafety Issue:
- Baseline characteristics (comorbidity) of the cases with hypothyroidism and of the rest of the cohortdate_rangeTime Frame:Prior to first examinationenhanced_encryptionNoSafety Issue:
- Baseline characteristics (sum of examinations) in cases with an indication of hypothyroidism and cases withoutdate_rangeTime Frame:Up to one year after ICM exposure (828 person years)enhanced_encryptionNoSafety Issue:
- Baseline characteristics (type of 1st examination) in cases with an indication of hypothyroidism and cases withoutdate_rangeTime Frame:Up to one year after ICM exposure (828 person years)enhanced_encryptionNoSafety Issue:
- Baseline characteristics (type of 2nd examination) in cases with an indication of hypothyroidism and cases withoutdate_rangeTime Frame:Up to one year after ICM exposure (828 person years)enhanced_encryptionNoSafety Issue:
- Baseline characteristics (time between examinations) in cases with an indication of hypothyroidism and cases withoutdate_rangeTime Frame:Up to one year after ICM exposure (828 person years)enhanced_encryptionNoSafety Issue:
- Time-relation between iodine contrast exposure and diagnosis of hypothyroidismdate_rangeTime Frame:Up to one year after ICM exposure (828 person years)enhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to one year after ICM exposure (828 person years)enhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:Up to one year after ICM exposure (828 person years)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A